MAUDE Adverse Event Report: TELEFLEX MEDICAL HOL L 10MM ENDO APPLIER; APPLIER, SURGICAL, CLIP

Catalog Number 544995

Device Problems Premature Activation (1484); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2018

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 at the second use of the applier it started to have problems closing the clips and one of them fell inside the patient's cavity therefore the physician needed to use another applier to extract the clip.

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 (b)(4) as part of a 50 pc.Lot in august of 2015.The returned instrument was evaluated and found that as received the handle mechanism does not connect to the jaw mechanism when squeezed thus making it impossible to open jaws to pick-up, retain, close and release a clip thus we are able to validate the alleged complaint.Further evaluation revealed that once disassembled the bottom end of the drive rod (n00190) where it engages with the jaws was broken off and separated from the rest of the drive rod.Parts were 100% visually inspected and function tested at the (b)(4) before instruments were sent to customer.No irregularities were found and or reported at the time of inspection and assembly of the product, as this is a standardized process for all instruments manufactured at this facility.We are unable to determine how this instrument has been used, stored, handled and cleaned by the end users facility.At this time it is undetermined as to how the end of the drive rod broke off at the jaw end but mishandling at the end users facility is suspected.

Event Description

It was reported that at the second use of the applier it started to have problems closing the clips and one of them fell inside the patient's cavity therefore the physician needed to use another applier to extract the clip.

• Brand Name: HOL L 10MM ENDO 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: 7565030
• MDR Text Key: 109909131
• Report Number: 3011137372-2018-00134
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: EC
• 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: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 544995
• Device Lot Number: 06C1515996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2018
• 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