MAUDE Adverse Event Report: CONMED CORPORATION KITTNER SINGLE TIP BLUNT DISSECTOR; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number CD801

Device Problems Material Fragmentation (1261); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/26/2019

Event Type  malfunction  

Manufacturer Narrative

The device in question has been received by conmed and has entered into the evaluation process.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

On behalf of the customer, the conmed sales representative reported an issue with the kittner single tip blunt dissector, item # cd801, lot # 201901211 that occurred (b)(6) 2019 at the (b)(6) hospital.It was reported only that the "tip of lap kittner fell off during the procedure" it is marked that the procedure was successfully completed by using another kittner device and there was no injury to the patient or user.The issue occurred during a video-assisted thoracoscopic procedure.Although requested, no other additional information was made available at this time.When additional information is provided, reportability of this incident will be reassessed.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence due to the tip falling off during a procedure.

Manufacturer Narrative

H11: d4 and h4 corrected information due to received product and clarification of lot number of complained device.H10: the reported complaint of the tip falling off is confirmed.Conmed received one cd801 in opened original packaging.The lot number of the product retuned, 201910211 did not match the lot number in the original reported data entry.Clarification was received from the reporter and the lot number was corrected from 201901211 to 201910211.A visual inspection was performed of the returned device and found the kittner tip had fallen out of the shaft.There are no signs of crimping on the shaft.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 and found no abnormalities that would contribute to this issue.A two-year lot history review shows this is the only complaint for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of (b)(4) 2 complaints, regarding (b)(4) 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 0.00002.The instructions for use (ifu) provides the user with information regarding proper care and use of this device.The ifu also advises the user that the laparoscopic kittner is used for blunt dissection and should be inserted through properly placed laparoscopic cannula.Additionally, conmed encourages the inspection and/or test of all medical equipment prior to use to ensure all devices are functioning as expected.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: KITTNER SINGLE TIP BLUNT DISSECTOR
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 9616256
• MDR Text Key: 183302539
• Report Number: 1320894-2020-00013
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K955490
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/11/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: CD801
• Device Lot Number: 201910211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Initial Date Manufacturer Received: 12/31/2019
• Initial Date FDA Received: 01/22/2020
• Supplement Dates Manufacturer Received: 01/06/2020
• Supplement Dates FDA Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1