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

Model Number	G22629
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter; occupation: unknown.Investigation evaluation: the product said to be involved was returned in an open pouch from the lot number provided in the report.The label matches the product returned.The customer provided an image of the handle.The rpn on the handle matches the rpn provided in the report.The sheath is detached from the distal end of the handle, leaving a gap where the drive wire is exposed.Our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the catheter pulled out from the distal end of the handle and the snare was advanced 1.9 cm from the catheter.The snare could not be retracted due to the catheter being detached from the handle.The catheter was removed from the device and observed under magnification.The catheter flare is deformed due to being pulled out from the cap.Due to the condition of the device, an accurate angle measurement on the flare of the catheter was not possible.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 complaint was confirmed, the device was returned with the catheter detached from the handle.A root cause could not be determined.Prior to distribution, all acusnare polypectomy snare are subjected to a visual inspection and functional test to ensure proper workability.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 and this represents an isolated occurrence.The likelihood of occurrence is considered remote.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 esophagogastroduodenoscopy (egd), the physician used a cook acusnare polypectomy snare.The user advanced the device to the desired position and pushed the snare out of the sheath to capture the polyp and found out that the sheath near the handle was broken.The user changed to another one of the same device to complete the procedure.Per further information received the user did not have difficulty retracting the snare.Our evaluation of the returned device on 07-jan-2021 determined that the snare was advanced and could not be retracted due to the catheter being detached from the handle (subject of this report).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.

• 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: 11246090
• Report Number: 1037905-2021-00037
• Device Sequence Number: 17017673
• Product Code: KNS
• UDI-Device Identifier: 00827002226296
• UDI-Public: (01)00827002226296(17)230129(10)W4314414
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 01/29/2021

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: 01/29/2023
• Device Model Number: G22629
• Device Catalogue Number: AS-1-S
• Device Lot Number: W4314414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 01/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 63