MAUDE Adverse Event Report: COOK ENDOSCOPY ACUSNARE POLYPECTOMY SNARE; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	G22630
Medical Device Problem Code	Failure to Conduct (1114)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter; occupation: unknown.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 customer provided three photos.The first photo has three devices pictured, the distal end of the handle is visible and the catheter area is severely damaged and crinkled on all three devices.The second photo matches the reference part number and lot number in the report.The third photo is of various biopsies in three different containers, that are being prepped for further examination.The biopsies are all different sizes and consistencies.The report is considered confirmed based solely on the pictures provided.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 contain the following information to assist with proper set-up and use of the device: "before using this device, follow recommendations provided by electrosurgical unit manufacturer to ensure patient safety through proper placement and utilization of patient return electrode.Ensure a proper path from patient return electrode to electrosurgical unit is maintained throughout the procedure." "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." "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." "following electrosurgical unit manufacturer's instructions for settings, verify desired settings and activate electrosurgical unit.Note: maximum rated input voltage for this device is 2kvp-p for cut mode and 5 kvp-p for coagulation mode." 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 or Problem Description
During an endoscopic mucosal resection procedure, the physician used three (3) acusnare polypectomy snares.The devices were not conducting electricity.The physician then changed to another manufacture's snare to complete the procedure.Hot biopsy forceps were used to clean the wound and the wound was closed with a harmony clamp.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Continued: section e.Initial reporter; occupation: unknown.Investigation evaluation: the customer provided three photos.The first photo has three devices pictured, the distal end of the handle is visible and the catheter area is severely damaged and crinkled on all three devices.The second photo matches the rpn and lot number in the report.The third photo is of various biopsies in three different containers, that are being prepped for further examination.The biopsies are all different sizes and consistencies.Device 1: our laboratory evaluation of the product said to be involved confirmed damage to the catheter but did not confirm the device could not be electrified.The device was returned with the snare fully retracted into the tubing.The snare was advanced and retracted using the handle with no issues.During a visual inspection of the device, there were kinks and bends along 3cm of the catheter near the distal end of the handle.The kinks did not affect the functionality of the device.The continuity from the electrical pin to the snare head was tested with an ohm meter and passed.An additional functional test was performed by attaching the active cord to the electrical pin.The active cord connected easily and remained securely connected to the device.The device was connected to a valley lab generator and power was applied.The snare cut simulated tissue as expected.Device 2: our laboratory evaluation of the product said to be involved could not confirm the report as it was described.The device was returned with the snare fully retracted into the tubing.The snare was advanced and retracted using the handle with no issues.During a visual inspection of the device, there was no damage noted on the device.The continuity from the electrical pin to the snare head was tested with an ohm meter and passed.An additional functional test was performed by attaching the active cord to the electrical pin.The active cord connected easily and remained securely connected to the device.The device was connected to a valley lab generator and power was applied.The snare cut simulated tissue as expected.Device 3: our laboratory evaluation of the product said to be involved confirmed damage to the catheter but did not confirm the device could not be electrified.The device was returned with the snare fully retracted into the tubing.The snare was advanced and retracted using the handle with no issues.During a visual inspection of the device, there were kinks and bends along 3cm of the catheter near the distal end of the handle.The kinks did not affect the functionality of the device.The continuity from the electrical pin to the snare head was tested with an ohm meter and passed.An additional functional test was performed by attaching the active cord to the electrical pin.The active cord connected easily and remained securely connected to the device.The device was connected to a valley lab generator and power was applied.The snare cut simulated tissue as expected.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: a definitive cause for the reported observation could not be determined because the product said to be involved functioned as intended.The bending and kinking of the catheter at the handle can occur during polyp removal if excess force is placed on the device.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.The instructions for use contain the following information to assist with proper set-up and use of the device: "before using this device, follow recommendations provided by electrosurgical unit manufacturer to ensure patient safety through proper placement and utilization of patient return electrode.Ensure a proper path from patient return electrode to electrosurgical unit is maintained throughout the procedure." "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." "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." "following electrosurgical unit manufacturer's instructions for settings, verify desired settings and activate electrosurgical unit.Note: maximum rated input voltage for this device is 2kvp-p for cut mode and 5 kvp-p for coagulation mode." 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.

• Brand Name: ACUSNARE POLYPECTOMY SNARE
• Common Device Name: KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 11567428
• Report Number: 1037905-2021-00131
• Device Sequence Number: 3521173
• Product Code: KNS
• UDI-Device Identifier: 00827002226302
• UDI-Public: (01)00827002226302(17)220429(10)W4208763
• Combination Product (Y/N): N
• PMA/510(K) Number: K851958
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

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: 04/29/2022
• Device Model Number: G22630
• Device Catalogue Number: ASJ-1-S
• Device Lot Number: W4208763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Initial Date Received by Manufacturer: 03/03/2021
• Supplement Date Received by Manufacturer: 05/03/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ERBE GENERATOR; OLYMPUS 260 ENDOSCOPE
• Patient Age: 61 YR