MAUDE Adverse Event Report: CONMED CORPORATION SINGULAR SMALL OVAL POLYPECTOMY SNARE; SNARE, FLEXIBLE

Catalog Number	000985
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One (1) "used/damaged" singular small oval polypectomy snare was returned for evaluation of "the wire came out of the catheter completely upon the first pass and fell out into the patient." a visual inspection of the device noted the loop of the snare had been completely detached from the connector.There is minimal or no deformation of the loop wire indicating no excessive force was applied to the device.Examination of the connector confirms the presence of a crimp, therefore, this complaint is confirmed.The device was manufactured on 13-january-2016.A review of the manufacturing documents from the dhr/lhr has verified the devices were produced according to current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified during manufacture.Of the lot containing (b)(4) devices there were 3 similar complaints for "detached loop." a 2-year review of product history for this device family revealed (b)(4) complaints involving (b)(4) were confirmed.To date, there has been no patient long term adverse effects reported regarding any of the reported incidents.(b)(4).This failure mode is addressed in the risk documents.A corrective action preventative action has been initiated to investigate the root cause of loop detachment.The conmed singular polypectomy snares are single patient use, disposable devices consisting of a proximal handle, outer sheath, internal drive wire, and distal wire loop.The instructions for use (ifu) states: inspect the snare device for kinks, fraying wire or any other damage that may have occurred during transit.Open and close the snare loop to confirm smooth movement.Do not use if the snare device is damaged.
Event or Problem Description
As reported by user facility, on (b)(6) 2017, during a colonoscopy, the surgeon deployed the snare and the wire came out of the catheter completely upon the first pass and fell into the patient.The entire wire came out, leaving nothing attached to the catheter.It was promptly retrieved by the doctor and removed.There was no surgical delay or patient injury.This report is being filed based on the potential for injury with recurrence.

• Brand Name: SINGULAR SMALL OVAL POLYPECTOMY SNARE
• Common Device Name: SNARE, FLEXIBLE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 6394867
• Report Number: 3007305485-2017-00052
• Device Sequence Number: 48010
• Product Code: FDI
• UDI-Device Identifier: 00653405053326
• UDI-Public: (01)00653405053326(17)180112(30)1(10)201601134
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K820430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/10/2017

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: Physician
• Device Expiration Date: 01/12/2018
• Device Catalogue Number: 000985
• Device Lot Number: 201601134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2017
• Initial Report FDA Received Date: 03/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR
• Patient Weight: 77