MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. RELOADS FOR LINEAR CUTTERS; STAPLE, IMPLANTABLE

Model Number	6R45B
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a thoracoscopic pneumonectomy, the deployed staples were unformed.The same issue occurred in two cartridges.The device was used on the lung parenchyma.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
Additional Manufacturer Narrative
(b)(4).Batch # unk.An analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances / manufacturing irregularities were identified.As part of ethicon's quality process, all devices are manufactured, inspected, and distributed to approved specifications.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested, and the following was obtained: the cartridge was replaced to fire the device again on where the staples were unformed.The procedure was not converted.The stapler will not be returning.The patient¿s condition is stable.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/20/2022.Incorrect information: an analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances / manufacturing irregularities were identified.As part of ethicon's quality process, all devices are manufactured, inspected, and distributed to approved specifications.Corrected information: an evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/24/2022.D4: batch #u5ed5y.Investigation summary: the product was returned to ethicon endo-surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the 6r45b (b) reload was received with no apparent damaged.The reload was received fully fired.No functional test could be performed due the condition of the device.Although no conclusion could be reached on the cause of the reported event, the instructions for use do contain the following caution: close the jaws of the instrument by squeezing the closing trigger until it locks in place.An audible click indicates that the closing trigger is locked.Once in the cavity, press the anvil release button to reopen the instrument jaws and return the closing trigger to its original position.To articulate the instrument, turn the articulating lever until it comes to a stop in either direction.To rotate the instrument, turn the rotating knob by applying pressure in a clockwise or counter-clockwise direction.The instrument shaft will rotate freely in either direction.Position the instrument around the tissue to be stapled.The tissue should be positioned between the black line at the distal end of the jaws and the black line at the proximal end, indicating the end of the staple line.The inner black line references the cut line of the device.After positioning the instrument jaws, close the jaws by squeezing the closing trigger until it locks.An audible click indicates that the closing trigger and jaws are locked.Holding the jaws in place for 15 seconds after closing and prior to firing may result in better compression and staple formation.Fire the instrument by squeezing the firing trigger completely with one continuous, smooth stroke until it rests on the closing trigger.To open the jaws, squeeze the closing trigger, and then simultaneously press the anvil release button.While pressure is still on the anvil release button, slowly release the closing trigger.Gently pull the instrument away from the transected tissue and ensure the tissue is released from the jaws.To remove the instrument from the cavity, squeeze the closing trigger until it locks, closing the jaws.Remove the instrument through the trocar in the closed position.The event could not be confirmed as the reload was received fully fired.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Visual analysis of the returned sample revealed that the 6r45b (c) reload was received with no apparent damaged.The reload was received fully fired.No functional test could be performed due the condition of the device.Although no conclusion could be reached on the cause of the reported event, the instructions for use do contain the following caution: close the jaws of the instrument by squeezing the closing trigger until it locks in place.An audible click indicates that the closing trigger is locked.Once in the cavity, press the anvil release button to reopen the instrument jaws and return the closing trigger to its original position.To articulate the instrument, turn the articulating lever until it comes to a stop in either direction.To rotate the instrument, turn the rotating knob by applying pressure in a clockwise or counter-clockwise direction.The instrument shaft will rotate freely in either direction.Position the instrument around the tissue to be stapled.The tissue should be positioned between the black line at the distal end of the jaws and the black line at the proximal end, indicating the end of the staple line.The inner black line references the cut line of the device.After positioning the instrument jaws, close the jaws by squeezing the closing trigger until it locks.An audible click indicates that the closing trigger and jaws are locked.Holding the jaws in place for 15 seconds after closing and prior to firing may result in better compression and staple formation.Fire the instrument by squeezing the firing trigger completely with one continuous, smooth stroke until it rests on the closing trigger.To open the jaws, squeeze the closing trigger, and then simultaneously press the anvil release button.While pressure is still on the anvil release button, slowly release the closing trigger.Gently pull the instrument away from the transected tissue and ensure the tissue is released from the jaws.To remove the instrument from the cavity, squeeze the closing trigger until it locks, closing the jaws.Remove the instrument through the trocar in the closed position.The event could not be confirmed as the reload was received fully fired.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Visual analysis of the returned sample revealed that the 6r45b (a) reload was received with no apparent damaged.The reload was received fully fired.No functional test could be performed due the condition of the device.Although no conclusion could be reached on the cause of the reported event, the instructions for use do contain the following caution: close the jaws of the instrument by squeezing the closing trigger until it locks in place.An audible click indicates that the closing trigger is locked.Once in the cavity, press the anvil release button to reopen the instrument jaws and return the closing trigger to its original position.To articulate the instrument, turn the articulating lever until it comes to a stop in either direction.To rotate the instrument, turn the rotating knob by applying pressure in a clockwise or counter-clockwise direction.The instrument shaft will rotate freely in either direction.Position the instrument around the tissue to be stapled.The tissue should be positioned between the black line at the distal end of the jaws and the black line at the proximal end, indicating the end of the staple line.The inner black line references the cut line of the device.After positioning the instrument jaws, close the jaws by squeezing the closing trigger until it locks.An audible click indicates that the closing trigger and jaws are locked.Holding the jaws in place for 15 seconds after closing and prior to firing may result in better compression and staple formation.Fire the instrument by squeezing the firing trigger completely with one continuous, smooth stroke until it rests on the closing trigger.To open the jaws, squeeze the closing trigger, and then simultaneously press the anvil release button.While pressure is still on the anvil release button, slowly release the closing trigger.Gently pull the instrument away from the transected tissue and ensure the tissue is released from the jaws.To remove the instrument from the cavity, squeeze the closing trigger until it locks, closing the jaws.Remove the instrument through the trocar in the closed position.The event could not be confirmed as the reload was received fully fired.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Visual analysis of the returned sample revealed that the 6r45b (e) reload was received with no apparent damaged.The reload was received fully fired.No functional test could be performed due the condition of the device.Although no conclusion could be reached on the cause of the reported event, the instructions for use do contain the following caution: close the jaws of the instrument by squeezing the closing trigger until it locks in place.An audible click indicates that the closing trigger is locked.Once in the cavity, press the anvil release button to reopen the instrument jaws and return the closing trigger to its original position.To articulate the instrument, turn the articulating lever until it comes to a stop in either direction.To rotate the instrument, turn the rotating knob by applying pressure in a clockwise or counter-clockwise direction.The instrument shaft will rotate freely in either direction.Position the instrument around the tissue to be stapled.The tissue should be positioned between the black line at the distal end of the jaws and the black line at the proximal end, indicating the end of the staple line.The inner black line references the cut line of the device.After positioning the instrument jaws, close the jaws by squeezing the closing trigger until it locks.An audible click indicates that the closing trigger and jaws are locked.Holding the jaws in place for 15 seconds after closing and prior to firing may result in better compression and staple formation.Fire the instrument by squeezing the firing trigger completely with one continuous, smooth stroke until it rests on the closing trigger.To open the jaws, squeeze the closing trigger, and then simultaneously press the anvil release button.While pressure is still on the anvil release button, slowly release the closing trigger.Gently pull the instrument away from the transected tissue and ensure the tissue is released from the jaws.To remove the instrument from the cavity, squeeze the closing trigger until it locks, closing the jaws.Remove the instrument through the trocar in the closed position.The event could not be confirmed as the reload was received fully fired.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Visual analysis of the returned sample revealed that the 6r45b (d) reload was received with no apparent damaged.The reload was received fully fired.No functional test could be performed due the condition of the device.Although no conclusion could be reached on the cause of the reported event, the instructions for use do contain the following caution: close the jaws of the instrument by squeezing the closing trigger until it locks in place.An audible click indicates that the closing trigger is locked.Once in the cavity, press the anvil release button to reopen the instrument jaws and return the closing trigger to its original position.To articulate the instrument, turn the articulating lever until it comes to a stop in either direction.To rotate the instrument, turn the rotating knob by applying pressure in a clockwise or counter-clockwise direction.The instrument shaft will rotate freely in either direction.Position the instrument around the tissue to be stapled.The tissue should be positioned between the black line at the distal end of the jaws and the black line at the proximal end, indicating the end of the staple line.The inner black line references the cut line of the device.After positioning the instrument jaws, close the jaws by squeezing the closing trigger until it locks.An audible click indicates that the closing trigger and jaws are locked.Holding the jaws in place for 15 seconds after closing and prior to firing may result in better compression and staple formation.Fire the instrument by squeezing the firing trigger completely with one continuous, smooth stroke until it rests on the closing trigger.To open the jaws, squeeze the closing trigger, and then simultaneously press the anvil release button.While pressure is still on the anvil release button, slowly release the closing trigger.Gently pull the instrument away from the transected tissue and ensure the tissue is released from the jaws.To remove the instrument from the cavity, squeeze the closing trigger until it locks, closing the jaws.Remove the instrument through the trocar in the closed position.The event could not be confirmed as the reload was received fully fired.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Visual analysis of the returned sample determined that the 6r45b reload (f) was received with no apparent damaged and partially fired 1/10 and with the reload lock out spring normal.No functional test could be performed due to the condition of the reload.The condition of the reload indicates that the device's firing cycle was interrupted.When firing the device make sure that the firing stroke is completed.Do not partially fire the device.Fire the device by squeezing the firing trigger completely until it rests on the closing trigger.Once the firing cycle has been initiated, it must be completed.If re-initiation of firing is resumed, the device will lockout.Firing through the lockout mechanism will break the device.Please reference the instruction for use for more information.Visual analysis of the returned sample determined that the 6r45b reload (g) was received with no apparent damaged and partially fired 1/10 and with the reload lock out spring normal.No functional test could be performed due to the condition of the reload.The condition of the reload indicates that the device's firing cycle was interrupted.When firing the device make sure that the firing stroke is completed.Do not partially fire the device.Fire the device by squeezing the firing trigger completely until it rests on the closing trigger.Once the firing cycle has been initiated, it must be completed.If re-initiation of firing is resumed, the device will lock out.Firing through the lockout mechanism will break the device.Please reference the instruction for use for more information.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• Brand Name: RELOADS FOR LINEAR CUTTERS
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; 6107428552
• MDR Report Key: 13661304
• Report Number: 3005075853-2022-01319
• Device Sequence Number: 17421035
• Product Code: GDW
• UDI-Device Identifier: 10705036000846
• UDI-Public: 10705036000846
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Model Number: 6R45B
• Device Catalogue Number: 6R45B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2022
• Supplement Date Received by Manufacturer: 02/24/2022; 04/26/2022
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 04/20/2022; 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown