MAUDE Adverse Event Report: CONMED CORPORATION ELECT,NEEDL,7/8",ANGL,3"LG,HY; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 711B

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The reported device is being returned to conmed for evaluation.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

The sales representative reported on behalf of the customer that the 711b devices (15 devices total) are cracking.There was no report of a specific procedure or date of event.There was no report of user or patient impact.Further assessment information has been requested; however, no response has been received to date.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Further assessment information was received from the reporter on 8aug19.It was stated that the "crack became evident when trying to fit the tip into the cautery handle" and that the device was "pulled out of circulation, new tip used for remainder of case".Therefore, it is thought that the device was not used on a patient.(15) 711b were received in opened unoriginal packaging, the reported catalog number was verified, the lot number was not reported nor was any lot number available with the returned samples.Visual inspection found that all 15 samples did not have the molded polysulfone.Visual inspection was unable to find any cracks anywhere along the needle.Visual inspection found remnants of the polysulfone indicating that it had been present previously.Due to the lack of polysulfone, the molded area was unable to be inspected for cracks.The manufacturing document of the device history record could not be reviewed since the lot number of the devices is unknown.(b)(4).Per the instructions for use, the user is advised the following: contraindications: these devices should never be used when: there is visible evidence of damage to the exterior of the device, such as cracks, cuts, punctures, nicks, abrasions, discoloration or connector damage.Inspection: these devices should be inspected before use and discarded if damage is found.Visually examine the devices for obvious physical damage: cracked, broken or otherwise distorted plastic parts damage including cuts, punctures, nicks, abrasions, unusual lumps or significant discoloration.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: ELECT,NEEDL,7/8",ANGL,3"LG,HY
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 8827369
• MDR Text Key: 152245151
• Report Number: 1320894-2019-00262
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K800617
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 711B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Date Manufacturer Received: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1