|
COOK ENDOSCOPY ACUSNARE POLYPECTOMY SNARE; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
|
Back to Search Results |
|
| Catalog Number ASDB-15-015-S |
| Device Problem
Failure to Cut (2587)
|
| Patient Problem
No Consequences Or Impact To Patient (2199)
|
| Event Date 03/30/2018 |
|
Event Type
malfunction
|
|
Manufacturer Narrative
|
|
Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.The user indicated the device was used for "underwater endoscopic mucosal resection" which is a novel procedure.In an effort to understand if the procedure could have contributed to the reported difficulty, an experimental test was performed using a sealed cook acusnare polypectomy snare device (from a different lot number) to test if the snare would cut or cauterize underwater.During the test, an active cord was connected to the device.The device was connected to a valley lab generator and power was supplied.The simulated tissue was placed in an underwater environment.The snare cut and cauterized the simulated tissue.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.The instructions for use (ifu) includes the following to ensure proper use of the device, "inspect active cord.Cord must be free of kinks, bends, breaks, and exposed wires to allow for accurate transfer of current.If an abnormality is noted, do not use active cord." the ifu states: "with electrosurgical unit off, prepare equipment.Securely connect active cord to device handle and electrosurgical unit.Active cord fittings should fit snugly into both device handle and electrosurgical unit.Following instructions from electrosurgical unit manufacturer, position patient return electrode and connect it to electrosurgical unit." the ifu also states: "advance snare wire out of sheath and position it around polyp to be removed.Warning: when applying current, tissue must be isolated from surround mucosa.Failure to isolate tissue may cause fulguration of normal mucosa and/or perforation.Contact of snare wire with endoscope during electrosurgery may cause grounding, which could result in injury to patient and/or operator as well as damage to endoscope and/or snare wire." prior to distribution, all acusnare polypectomy snares are subjected to a visual inspection and functional testing to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
|
| |
|
Event Description
|
|
During an underwater endoscopic mucosal resection, the physician used three (3) acusnare polypectomy snares.The snares stuck to the tissue and would not excise, despite the use of electrocautery.They were able to complete the procedure successfully with a fourth device.
|
| |
|
Manufacturer Narrative
|
|
Continued from section h6- event problem and evaluation code.Method code- 38.Method code- 3331.Method code- 3345.Investigation evaluation: two (2) of the products said to be involved were returned in open pouches from the lot number provided in the report.Additionally, five (5) sealed devices were returned from the lot number provided in the report.Device 1 (used): our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the snare head not fully retracted inside the distal end of the sheath.The snare head was resting outside the distal end of the sheath and would not fully retract.The handle of the device was manipulated to advance the snare head, and when the snare head was advanced outside the sheath, the snare head was misshaped.The snare head did not form the duck bill shape.The snare head was advanced outside the sheath, and the snare wire was bent above where the duck bill is normally formed.This created two (2) bends in the snare wire.One (1) bend that is made to create the duck bill shape, and one (1) bend that was created during use; thus, creating a misshaped snare head.The misshaped snare head contributed to the retraction difficulty that the user encountered.Further, when the snare head is being retracted into the sheath, the additional bend in the snare wire is preventing the snare head from fully retracting.The snare wire was manipulated with a pair of tweezers and formed back into a duck bill shape with one bend in the distal end of the wire.After the snare wire was formed, the snare head retracted fully inside the sheath.When the snare head was fully retracted, the snare head distance (from the distal end of the snare wire to the distal end of the sheath) did not meet manufacturing specification.The sheath of the snare was disassembled from the handle to evaluate the formed snare wire.It was found during the evaluation that the snare wire cannula was not in the correct location.The position of this cannula could have contributed to the snare head becoming misshaped during use.The manufacturing instructions tell the operator to position the components to specification and verify length.The location of the cannula of this device did not meet the required specification.Device 2 (used): our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the snare head retracted inside the distal end of the sheath.When the handle was manipulated and the snare head was advanced, the snare did not form a duck bill shape.The snare head would retract back inside the sheath; however, resistance was encountered.The snare wire was manipulated with a pair of tweezers and formed back into a duck bill shape with one bend in the distal end of the wire.When the snare head was fully retracted, the snare head distance meets specification.The sheath of the snare was disassembled from the handle to evaluate the formed snare wire.It was found during the evaluation of the snare wire cannula was not in the correct location.The position of this cannula could have contributed to the snare head becoming misshaped during use.The location of the cannula of this device did not meet the required specification.Unused, sealed devices: a functional test was performed on all five (5) sealed devices.The functional test was set up to test the devices to see if the snares would cut and/or cauterize underwater.The user indicated that the used devices were used for "underwater endoscopic mucosal resection", which is a novel procedure.Device 1 (unused): our laboratory evaluation of the sealed device could not confirm the report.The handle of the device was manipulated and the snare head advanced and retracted without any resistance felt.A functional test was performed on the device.During the test, an active cord was connected to the device.The continuity from the electrical pin to the snare head was tested with an ohm meter and passed.The device was connected to a valley lab generator and power was supplied.The simulated tissue was placed under water.The snare cut and cauterized the simulated tissue.The snare head of the device remained uniform during the functional test.A further investigation was performed to verify the snare head is retracted at the correct distance and to verify if the snare wire cannula is in the correct location.When the snare head was fully retracted, the snare head distance meets specifications.The sheath of the snare was disassembled from the handle to evaluate the formed snare wire.It was found during the evaluation that the snare wire cannula is in the correct location.The location of the cannula meets the required specification.Device 2 (unused): our laboratory evaluation of the sealed device confirmed the report.The handle of the device was manipulated and the snare head advanced and retracted without any resistance felt.A visual inspection of the snare head was performed under magnification.The solder appeared to be above the specified location of the snare wire cannula.The solder is intended to connect the snare wire cannula to the snare wire.The solder is not intended to be on the snare wire anywhere other than the snare wire cannula, because it creates a rough surface.The manufacturing instructions tell the operator to verify that the soldered area is smooth.A functional test was performed on the device.During the test, an active cord was connected to the device.The continuity from the electrical pin to the snare head was tested with an ohm meter and passed.The device was connected to a valley lab generator and power was supplied.The simulated tissue was placed under water.When power was being supplied, the snare was retracted and it became stuck on the simulated tissue.The snare wire became misshaped.The simulated tissue was not removed successfully.When the snare head was removed from the simulated tissue, the snare head would no longer retract fully back into the distal end of the sheath.A further investigation was performed to verify the snare head is retracted at the correct distance and to verify if the snare wire cannula is in the correct location.When the snare head was fully retracted, the snare head distance meets specifications.The sheath of the snare was disassembled from the handle to evaluate the formed snare wire.It was found during the evaluation that the snare wire cannula was not in the correct location.The location of the cannula does not meet the required specification.Device 3 (unused): our laboratory evaluation of the sealed device confirmed the report.The handle of the snare was manipulated and when the snare head was advancing, the solder ball cannula advanced completely through the cannula that helps create the duck bill shape.A functional test was not performed because the snare head would not form correctly due to the solder ball being too small.A further investigation was performed to verify the snare head is retracted at the correct distance and to verify if the snare wire cannula is in the correct location.When the snare head was fully retracted, the snare head distance meets specifications.The sheath of the snare was disassembled from the handle to evaluate the formed snare wire.It was found during the evaluation that the snare wire cannula was not in the correct location.The location of the cannula does not meet the required specification.Device 4 (unused): our laboratory evaluation of the sealed device could not confirm the report.The handle of the device was manipulated and the snare head advanced and retracted without any resistance felt.A visual inspection of the snare head was inspected under magnification.The solder appeared to be below the specified location of the snare wire cannula.The solder is intended to connect the snare wire cannula to the snare wire.The solder is not intended to be on the snare wire anywhere other than the snare wire cannula, because it creates a rough surface.The manufacturing instructions tell the operator to verify that the soldered area is smooth.A functional test was performed on the device.During the test, an active cord was connected to the device.The continuity from the electrical pin to the snare head was tested with an ohm meter and passed.The device was connected to a valley lab generator and power was supplied.The simulated tissue was placed under water.The snare cut and cauterized the simulated tissue.The snare head of the device remained uniform during the functional test.A further investigation was performed to verify the snare head is retracted at the correct distance and to verify if the snare wire cannula is in the correct location.When the snare head was fully retracted, the snare head distance does not meet specification.The sheath of the snare was disassembled from the handle to evaluate the formed snare wire.It was found during the evaluation of that the snare wire cannula was in the correct location.The location of the cannula meets the required specification.Device 5 (unused): our laboratory evaluation of the sealed device could not confirm the report.The handle of the device was manipulated and the snare head advanced and retracted without any resistance felt.A functional test was performed on the device.During the test, an active cord was connected to the device.The continuity from the electrical pin to the snare head was tested with an ohm meter and passed.The device was connected to a valley lab generator and power was supplied.The simulated tissue was placed under water.The snare cut and cauterized the simulated tissue.The snare head of the device remained uniform during the functional test.A further investigation was performed to verify the snare head is retracted at the correct distance and to verify if the snare wire cannula is in the correct location.When the snare head was fully retracted, the snare head distance meets specifications.The sheath of the snare was disassembled from the handle to evaluate the formed snare wire.It was found during the evaluation that the snare wire cannula was not in the correct location.The location of the cannula does not meet the required specification.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: the investigation determined that the devices did not meet manufacturing specifications.During the manufacturing process for the forming wire, the cannula was not placed at the correct location prior to being soldered to the forming wire on five (5) of the seven (7) returned devices (device 2 (used) and device 3 (unused)).Additionally, two (2) of the devices (device 1 (used) and device 1 (unused)) had a snare wire that was the incorrect distance from the distal end of the sheath and did not meet manufacturing specifications.While observing operators in manufacturing, it was found that operators were not manufacturing the duckbill snare devices per the manufacturing instructions.A corrective action has been initiated to reduce occurrences for snare head retraction difficulties for acusnare polypectomy duckbill snare devices.The product said to be involved is included in the scope of the corrective actions.In the investigation, two (2) further issues were found.Two (2) of the sealed devices had soldered areas above or below where the cannula is soldered which did not create a smooth transition.One (1) of the sealed devices had a solder ball that was not formed correctly, which resulted in the device not being able to form a duck bill shape.Prior to distribution, all acusnare polypectomy snares are subjected to a visual inspection and functional testing to ensure device integrity.Corrective action: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.A corrective action has been initiated in an effort to reduce occurrences of this nature.This product is included in the scope of this corrective action.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
|
| |
|
Event Description
|
|
The following was reported to the fda on 04/27/2018: "during an underwater endoscopic mucosal resection, the physician used three (3) acusnare polypectomy snares.The snares stuck to the tissue and would not excise, despite the use of electrocautery.They were able to complete the procedure successfully with a fourth device." these three (3) devices were reported by the customer to be from lot w4025345.When the devices were received for evaluation on 05/02/2018, it was found that two (2) used devices had the registered product number asdb-15-15-s, from lot number w4025345 (subject of this report) and one (1) used device was a registered product number asdb-25-015-s from lot w4028177 (see related mdr 1037905-2018-00226).
|
| |
|
Search Alerts/Recalls
|
|
|
