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

Catalog Number 544990

Device Problems Separation Failure (2547); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2017

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

When we load the clip it gets stuck in the jaw and does not come out easily.There was no patient injury.

Event Description

When we load the clip it gets stuck in the jaw and does not come out easily.There was no patient injury.

Manufacturer Narrative

(b)(4).The dhr for the instrument in question, was reviewed and found completely without any irregularities.This instrument was manufactured at the tecomet, inc.Kenosha facility as part of a 50 pc.Lot in january of 2016.Since the instrument was not returned for evaluation and pictures were not provided we are unable to validate this complaint or determine root cause at this time.All instruments are thoroughly inspected and function tested at time of manufacture.No corrective action required at this time.

• 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: 6800301
• MDR Text Key: 82899112
• Report Number: 3011137372-2017-00268
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2021
• Device Catalogue Number: 544990
• Device Lot Number: 06G1521218
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1