MAUDE Adverse Event Report: TELEFLEX MEDICAL HOL ML 5 MILLIMETER ENDO APPLIER; APPLIER, SURGICAL, CLIP

Catalog Number 544965

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that during laparoscopic radical prostatectomy, when the user compressed the trigger of the applier, an abnormal sound was heard, and the jaws got bent.No parts or clips fell in the patient.

Manufacturer Narrative

(b)(4).The dhr for the returned device was reviewed and found completely without any irregularities.This instrument was produced at the tecomet , inc.Kenosha facility as part of a 50 pc.Lot produced in april of 2018.Returned product was evaluated and it was found that the outertube assembly at the jaw end is bent/damaged and the jaws are loose and misaligned to each other and the pivot pin is pulled thru on one side of the tube assembly and the drive rod is bent/damaged.This instrument was returned complete with all of its components.We are able to validate this complaint since this instrument is unusable in its current condition.All instruments produced at this facility are 100% visually inspected and function tested prior to shipment to the customer.We are unable to determine what caused this instrument to be damaged and unusable but mishandling at the end users facility is suspected.

Event Description

It was reported that during laparoscopic radical prostatectomy, when the user compressed the trigger of the applier, an abnormal sound was heard, and the jaws got bent.No parts or clips fell in the patient.

• Brand Name: HOL ML 5 MILLIMETER ENDO APPLIER
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8249364
• MDR Text Key: 133142038
• Report Number: 3011137372-2019-00015
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• 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: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 544965
• Device Lot Number: 06K1758660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Date Manufacturer Received: 02/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1