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

Catalog Number 544990

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/28/2018

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 the clip cannot be loaded into the applier properly, and it was easy to drop off the applier during the operation.The patient is fine.The applier was the newly purchased.

Manufacturer Narrative

(b)(4).The dhr for the alleged instrument was reviewed and found completely without any irregularities.This instrument was manufactured at the (b)(4) as part of an 50 pc.Lot in (b)(6) of 2017.The returned instrument was evaluated and found that the jaws are aligned properly with each other and the opened & closed jaw gaps meet print specifications.Further evaluation shows that this instrument is able to pick-up, retain, close and release multiple clips both with and without the use of silastic tubing as required of its function.We were unable to replicate the alleged issue therefore we are unable to validate the alleged complaint.

Event Description

It was reported that the clip cannot be loaded into the applier properly, and it was easy to drop off the applier during the operation.The patient is fine.The applier was the newly purchased.

• Brand Name: HEM-O-LOK XL ENDO 10, APPLIER
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 7621150
• MDR Text Key: 112161439
• Report Number: 3011137372-2018-00158
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 544990
• Device Lot Number: 06J1639936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1