MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*55MM LINEAR CUTTER; STAPLE, IMPLANTABLE

Model Number	TLC55
Medical Device Problem Codes	Failure to Fire (2610); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pc-(b)(4).Batch # 385a93.Device analysis: 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 tlc55 device was received with no apparent damage, with no reload present.The device was tested for functionality with a test reload and it fired, cut, formed all the staples as intended and the knife returned to the home position as expected.The staple line and cut line were complete, and the staples meet the staple form release criteria.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reached on the cause of the reported event, the instructions for use do contain the following caution: place the instrument across the tissue for transection or into the lumen to form an anastomosis.For instruments with no knife, place the instrument across the tissue to be stapled.With the alignment/locking lever in the completely opened position, join the instrument halves together by aligning from either the front, center or back of the instrument.To adjust tissue on the forks before firing, move the alignment/locking lever to the intermediate position.This allows maneuvering of the tissue while the instrument halves are joined.Close the alignment/locking lever completely when the tissue is properly in place.To fire the linear cutter, place the thumb on the firing knob and two fingers on the shoulders of the linear cutter.Fire the instrument by pushing the firing knob completely forward.Completely return the firing knob to the original ¿return knob here¿ position.Separate the instrument halves by opening the alignment/locking lever and remove the instrument.The event described could not be confirmed as the device performed without any difficulties.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Additional information was requested but not available: could you please provide more details for "the blade got stuck"? did the reload lock out and would not work? did the reload begin to staple and cut, but then jammed? did the device staple? if the device stapled, was the staple line complete? if the device stapled, what was the shape of the staples (b-formation, irregular, legs straight)? did the device cut? if the device cut, was the cut line complete? were the cut line and staple lines equal? did the device staple, but there was no cut line? did the knife did not return?.
Event or Problem Description
It was reported that during the unknown procedure, while the surgery resident was firing stapler, the blade got stuck.He was able to separate stapler pieces to remove from bowel.There was no patient harm.
Additional Manufacturer Narrative
(b)(4).Batch # 385a93.Device analysis: 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 tlc55 device was received with no apparent damage, with no reload present.The device was tested for functionality with a test reload and it fired, cut, formed all the staples as intended and the knife returned to the home position as expected.The staple line and cut line were complete, and the staples meet the staple form release criteria.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reached on the cause of the reported event, the instructions for use do contain the following caution: place the instrument across the tissue for transection or into the lumen to form an anastomosis.For instruments with no knife, place the instrument across the tissue to be stapled.With the alignment/locking lever in the completely opened position, join the instrument halves together by aligning from either the front, center or back of the instrument.To adjust tissue on the forks before firing, move the alignment/locking lever to the intermediate position.This allows maneuvering of the tissue while the instrument halves are joined.Close the alignment/locking lever completely when the tissue is properly in place.To fire the linear cutter, place the thumb on the firing knob and two fingers on the shoulders of the linear cutter.Fire the instrument by pushing the firing knob completely forward.Completely return the firing knob to the original ¿return knob here¿ position.Separate the instrument halves by opening the alignment/locking lever and remove the instrument.The event described could not be confirmed as the device performed without any difficulties.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Additional information was requested but not available: could you please provide more details for "the blade got stuck"? did the reload lock out and would not work? did the reload begin to staple and cut, but then jammed? did the device staple? if the device stapled, was the staple line complete? if the device stapled, what was the shape of the staples (b-formation, irregular, legs straight)? did the device cut? if the device cut, was the cut line complete? were the cut line and staple lines equal? did the device staple, but there was no cut line? did the knife did not return?.
Event or Problem Description
It was reported that during the unknown procedure, while the surgery resident was firing stapler, the blade got stuck.He was able to separate stapler pieces to remove from bowel.There was no patient harm.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 13598782
• Report Number: 3005075853-2022-01127
• Device Sequence Number: 1930063
• Product Code: GDW
• UDI-Device Identifier: 10705036013204
• UDI-Public: 10705036013204
• Combination Product (Y/N): N
• PMA/510(K) Number: K020779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/25/2022

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: 06/28/2026
• Device Model Number: TLC55
• Device Catalogue Number: TLC55
• Device Lot Number: 396A19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown