MAUDE Adverse Event Report: CONMED CORPORATION ADJUSTABLE RETRACTOR CANNULA 8.0MM X 65MM; ACCESSORIES, ARTHROSCOPIC

Catalog Number	C08-65
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The alleged c08-65 device is not expected to be returned for evaluation and review.This complaint of the washer/seal coming out of the device is unable to be verified and a root cause cannot be determined.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution were found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 7 complaints, regarding 7 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following: warnings: it is the surgeon's responsibility to be familiar with the appropriate surgical techniques prior to use.Precautions: inspect cannula prior to use to ensure they are in good physical condition.To avoid damaging seals and excessive leakage, do not use with device larger than the specified cannula diameter.Use carefully to ensure the cannula is not bent or collapsed when inserting devices.To avoid damage during use, do not use excessive force on cannula.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
This distributor reported on behalf of their customer that the c08-65, adjustable retractor cannula 8.0mm x 65mm, device had a white washer/seal come out of the device and fall into the patient during a shoulder scope procedure on (b)(6) 2018.The washer was removed from the patient causing a 10-minute delay in the procedure.There was no report of harm to the patient or the user and the procedure was completed successfully.Request for further information have been sent; however, no other information has been provided to date.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: ADJUSTABLE RETRACTOR CANNULA 8.0MM X 65MM
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 7790615
• Report Number: 1320894-2018-00192
• Device Sequence Number: 13738925
• Product Code: NBH
• UDI-Device Identifier: 00653405001631
• UDI-Public: (01)00653405001631(17)221126(10)201711271
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/16/2018

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: 11/26/2022
• Device Catalogue Number: C08-65
• Device Lot Number: 201711271
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 08/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1