MAUDE Adverse Event Report: TELEFLEX MEDICAL HOL ML ENDO APPLIER 5MM 45CM; APPLIER, SURGICAL, CLIP

Catalog Number 544965L

Device Problem Break (1069)

Patient Problems Blood Loss (2597); No Information (3190)

Event Date 09/12/2018

Event Type  Injury  

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 applier broke during an attempt to apply a green hem-o-lok clip.The surgical staff ended up using a "perple" hem-o-lok clip to control bleeding.The patient's current condition is unknown.

Manufacturer Narrative

(b)(4).Tecomet failure analysis and conclusions - we are unable to perform a thorough dhr review for the alleged instrument since it was not provided on submitted documentation and the instrument has not been returned for evaluation or investigation.We are unable to validate the alleged complaint.

Event Description

It was reported that the clip applier broke during an attempt to apply a green hem-o-lok clip.The surgical staff ended up using a perple hem-o-lok clip to control bleeding.The patient's current condition is unknown.

• Brand Name: HOL ML ENDO APPLIER 5MM 45CM
• 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: 8126189
• MDR Text Key: 129096508
• Report Number: 3011137372-2018-00317
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 544965L
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2019
• 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
• Patient Outcome(s): Required Intervention