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

Catalog Number	000991
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device return to conmed corporation is anticipated; however, the device has not been received to date.A supplemental report will be filed on completion of the quality engineering evaluation.Device not yet returned to conmed corp.
Event or Problem Description
It was reported by the end-user facility that during the use of a singular polypectomy snare, a piece of the snare broke off in the patient's colon when the snare was opened.Per report the piece was retrieved and removed from the patient immediately.The procedure was completed with no further complications, surgical delay or patient injury.To date, there has been no additional information received regarding the patient latest condition or any indication that a long term adverse effect has occurred.
Additional Manufacturer Narrative
One (1) 000991 disposable snare has been returned to the conmed quality assurance laboratory for evaluation.The device was examined; a visual inspection noted the loop and the drive wire were attached.The drive wire was fully connected to the handle and the loop was fully connected to the drive wire.The proximal end of the ptfe catheter was found detached from the handle.The device wire/loop assemble was found inserted in the catheter.Judging from the amount of kinking and stretching observed in the catheter it appears the device was caught in the elevator of the scope and pulled in an attempt to release it.The detachment of the catheter from the handle has not been observed or reported before.It is most probably a user related issue.There is little chance of the catheter detaching from the handle becoming a retained device fragment.This lot was manufactured 29-feb-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 was only this complaint received for detachment of components.A two (2) year review of product history for this device family showed a total of (b)(4) complaint (b)(4) device for catheter detachment.(b)(4).There have been no serious injuries related to this product and failure mode.The conmed singular polypectomy snares are single patient use, one piece, disposable device 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.Indications for use: may be used in conjunction with an electrosurgical generator for endoscopic resection of polypoid lesion.May be used without electrocautery to aid in grasping a placement guidewire or tether during percutaneous endoscopic gastrostomy (peg) or jejunal feeding tube placement.This product is designed for non-continuous operation, with a duty cycle of 10 seconds on, and 30 seconds off.The ifu states "remove the snare from the endoscope slowly to avoid biopsy channel damage.Warnings/precautions : this device is intended for single patient use only.The product and its 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.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.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 and endoscope with a minimum working channel of 2.8 mm.Snares are supplied sterile.If the package is opened or damaged, do not use or re-sterilize the device.

• Brand Name: SINGULAR POLYPECTOMY SNARE, EXTRA SMALL, OVAL
• Common Device Name: POLYPECTOMY SNARE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 5644690
• Report Number: 3007305485-2016-00041
• Device Sequence Number: 451981
• Product Code: FDI
• UDI-Device Identifier: 00653405053265
• UDI-Public: (01)00653405053265(17)180228(30)1(10)201602294
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2016

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: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 000991
• Device Lot Number: 201602294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/10/2016
• Supplement Report FDA Received Date: 07/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1