MAUDE Adverse Event Report: TELEFLEX MEDICAL HEM-O-LOK XL ENDO 10, APPLIER; APPLIER, SURGICAL, CLIP

Catalog Number 544990

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/12/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the clips were set on the applier.Once the applier was in the patient, the clip remained stuck in the applier.There was no patient injury.

Manufacturer Narrative

(b)(4).The dhr for the returned instrument was reviewed and found completely without any irregularities.This instrument was manufactured at the (b)(4) facility as part of a (b)(4).Lot in february of 2016.Evaluation of the returned instrument showed that this instrument is not damaged in any way and that it is able to pick-up, retain, close and release multiple clips both with and without the use of silastic test tubing therefore we are unable to validate the alleged complaint since we are unable to duplicate the alleged issue.As per repair lot coding of (b)(4) on instrument handle this instrument has been repaired previous to this complaint.We are unable to duplicate the alleged issue with this applier and no nonconformities were found on the returned device therefore we are unable to validate this complaint.

Event Description

It was reported that the clips were set on the applier.Once the applier was in the patient, the clip remained stuck in the applier.There was no patient injury.

Event Description

It was reported that the clips were set on the applier.Once the applier was in the patient, the clip remained stuck in the applier.There was no patient injury.

Manufacturer Narrative

Qn#(b)(4).Reported lot#06g1521219, updated upon instrument return.

• Brand Name: HEM-O-LOK XL ENDO 10, APPLIER
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 7371116
• MDR Text Key: 103532058
• Report Number: 3011137372-2018-00092
• 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,Followup
• Report Date: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 544990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Date Manufacturer Received: 04/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1