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

Catalog Number	000478
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the used device is not expected for evaluation as the unit was not returned from the user facility.Also, no photograph or visual evidence of the used/damaged trocar was provided for evaluation.Without the actual product, an evaluation could not be performed and the complaint therefore could not be verified.The root cause of the reported problem "loop detachment" was unable to be determined.This lot was manufactured on 16-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 that could have caused or contributed to reported breakage.Of the lot containing (b)(4) units, there was no other similar complaint received for this item and lot number combination.A 2-year review of product history for this device family showed a total of 27 complaints (including this one) with a total of 34 units for loop detachment.During this same 2-year time frame, over (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.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 the optimizer polypectomy snare in a colonoscopy procedure, the snare loop was detached in the patient and had to be retrieved with forceps.The case went on with no further complications or problems reported and the procedure was otherwise completed with no surgical delay or patient injury.This report is raised on the basis of potential injury with recurrence.

• Brand Name: OPTIMIZER 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: 5952941
• Report Number: 3007305485-2016-00112
• Device Sequence Number: 840098
• Product Code: FDI
• UDI-Device Identifier: 00653405053425
• UDI-Public: (01)00653405053425(17)180215(30)1(10)201602164
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/31/2016

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: 02/15/2018
• Device Catalogue Number: 000478
• Device Lot Number: 201602164
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2016
• Initial Report FDA Received Date: 09/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 142