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

Catalog Number 544965

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the applier would not hold clips properly.

Manufacturer Narrative

(b)(4).The dhr for this manufacturing lot exceeds our document retention history.An additional review was performed on recent complaints and nonconformances with no concerns noted.(1) sample of 544965 serial #(b)(4) was received for evaluation.The sample is >10 years old and is beyond its useful life.The distal rivet which holds the jaws has begun to separate from the outer tube.The jaws show signs of wear which is likely contributing to the reported failure.Based on the age and condition of the device it should have been removed from service.The device has exceeded expected life and no further investigation is required.

Event Description

It was reported that the applier would not hold clips properly.

• 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: 8707536
• MDR Text Key: 148288762
• Report Number: 3011137372-2019-00175
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/21/2019

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: 544965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Initial Date Manufacturer Received: 05/21/2019
• Initial Date FDA Received: 06/18/2019
• Supplement Dates Manufacturer Received: 07/23/2019
• Supplement Dates FDA Received: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1