MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT OPTIM XSM OVAL OLY FIRM; OPTIMIZER POLYPECTOMY SNARE

Catalog Number	000478
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported 000478 snare is being returned to conmed for evaluation.Once the device is returned/evaluated and a complaint investigation has been completed, a supplemental report will be filed.
Event or Problem Description
During a colonoscopy the consultant fed 000478 snare down the scope and the snare head detached when placed over the polyp.Biopsy forceps were used to retrieve the detached snare head.The procedure was completed successfully using another conmed snare and a surgical delay was not reported.No patient injury reported.This report is raised on the basis of a device malfunction with potential for injury with recurrence.
Additional Manufacturer Narrative
The reported used device was not returned to conmed for evaluation, however, a photo was sent in from the facility.Visual inspection of the photo confirmed the snare head was detached.A likely cause for this detachment is unable to be determined due to the physical device not being evaluated.A review of the manufacturing documents has verified the devices were produced per current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified during manufacture that would contribute to this issue.(b)(4).There have been no prior complaints against this specific lot.A risk analysis was performed and this failure is addressed and deemed acceptable.The customer is advised of the following warning and precautions set forth in the instructions for use.-inspect the snare for kinks, fraying wire, or any other damage before use.-open and close the snare loop to confirm smooth movement before use.This incident type will continue to be monitored through the complaint system to assure patient safety.
Additional Manufacturer Narrative
An error was found during complaint closure.It was reported that 29 similar events have been reported, however, there have been a total of 23 similar reports.

• Brand Name: OPTIM XSM OVAL OLY FIRM
• Common Device Name: OPTIMIZER POLYPECTOMY SNARE
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; ave. alejandro dumas no. 11321; complejo industrial chihuahua; chihuahua, chihuahua 31136 ; MX 31136
• MDR Report Key: 6855968
• Report Number: 3007305485-2017-00196
• Device Sequence Number: 819973
• Product Code: FDI
• UDI-Device Identifier: 00653405053425
• UDI-Public: (01)00653405053425(17)190221(80)1(10)201702214
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K820430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/26/2017

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: Other
• Device Expiration Date: 02/21/2019
• Device Catalogue Number: 000478
• Device Lot Number: 201702214
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2017
• Supplement Date Received by Manufacturer: 10/11/2017; 10/26/2017
• Initial Report FDA Received Date: 09/11/2017
• Supplement Report FDA Received Date: 10/24/2017; 10/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR