MAUDE Adverse Event Report: CONMED CORPORATION SINGULAR POLYPECTOMY SNARE

Catalog Number	000959
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One (1) used/damaged device was returned to conmed for evaluation.Visual inspection noted the loop wire has detached from the connector/drive assembly.Examination of the connector shows insufficient crimping of the loop assembly connector.An investigation has been initiated to address this problem.This lot was manufactured 14-jan-2016.A review of the device history record for this lot found no ncr's and no note of discrepancies during the manufacturing process.Of the lot containing (b)(4) units, there has been (b)(4) complaints received for detachment of components from this lot.This lot was manufactured on 14-jan-2016.A review of the device history record for this lot found no ncr's and no note of discrepancies during the manufacturing process.Of the lot containing (b)(4) units, there have been a total of (b)(4) complaints received for the loop detachment including this one.A 2- year review of product history for this device family showed a total of (b)(4) complaints, consisting of (b)(4) devices for detachment of components.During this same 2-year time frame, (b)(4) units were sold worldwide making the occurrence rate for this reported failure mode (b)(4) percent.This failure mode is addressed in the risk document with an acceptable risk level.There have been no serious injuries related to any of the reported incidents.The conmed singular and conmed optimizer polypectomy snares are single patient use, one piece, disposable devices consisting of a proximal handle, outer sheath, internal drive wire, and distal wire loop.All parts of this device that exit the distal end of the endoscope are considered applied parts.To reduce the risk of breakage and injury to the patient, the instructions for use (ifu) provides the following precautions and warnings: - this device is intended for single patient use only.The product and the packaging have not been designed or tested for reuse.The ability to effectively clean and re-sterilize this single use device and subsequent reuse may adversely affect the clinical performance, safety and/or sterility of the device.- 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 snare device is damaged.- do not pretest the snare with electrocautery outside of the patient.This could cause overheating of the snare and cause it to fray or break during the procedure resulting in a potential burn to the patient.- to help prevent inadvertent injury or perforation of internal organs and body structure, polypectomy should always be performed under direct endoscopic vision.- the electrosurgical generator should be placed on the off position prior to advancing or removing the snare through the endoscope to avoid injury to the patient or equipment that results from improper electrical grounding.Ensure that the patient is grounded prior to use of the monopolar electrosurgical generator and polypectomy snare to avoid patient injury.- snares should only be used by or under the supervision of physicians thoroughly trained in endoscopic polypectomy and electrosurgical generator set-up and operation.Snares require an endoscope with a minimum working channel of 2.8 mm.
Event or Problem Description
The end user facility reported that during use of a singular polypectomy snare in a colonoscopy procedure on (b)(6) 2016 and while attempting to resect a polyp, the snare loop fell off the end of the catheter cable.The snare loop was retrieved from the patient colon with no problems reported.The colonoscopy was otherwise completed with no further complications or patient injury.This report is raised on the basis of potential injury with recurrence.

• Brand Name: SINGULAR POLYPECTOMY SNARE
• Common Device Name: POLYPECTOMY SNARE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 5933184
• Report Number: 3007305485-2016-00103
• Device Sequence Number: 16327188
• Product Code: FDI
• UDI-Device Identifier: 00653405053180
• UDI-Public: (01)00653405053180(17)180113(30)1(10)201601144
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K820430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/09/2016

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: No Information
• Device Expiration Date: 01/14/2018
• Device Catalogue Number: 000959
• Device Lot Number: 201601144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2016
• Initial Report FDA Received Date: 09/07/2016
• 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: 63 YR
• Patient Weight: 82