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

Catalog Number 544965

Device Problems Break (1069); Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device investigation report has not been submitted at this time.The manufacturer will continue to monitor and trend related events.

Event Description

The applier broke during surgery.The broken part fell into the patient and it was retrieved.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).The dhr for the returned instrument was reviewed and found completely without any irregularities, this instrument was produced at the tecomet, inc.(b)(4) in march of 2016 as part of a 35 pc.Lot.The returned instrument was evaluated and found that it was returned with the jaws off of the instrument and only one jaw was returned for the evaluation along with the instrument.During the evaluation, it was noticed that both pins on the drive rod which activates the jaws are damaged and one leg of the tube assembly is bent signifying that this instrument has been mishandled in some way.Parts were 100% visually inspected and tested at the tecomet (b)(4) facility 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.At this time, it is undetermined as to how the jaw fell off of this instrument and fell into the patient, but mishandling at the customer facility is suspected.No corrective action required at this time.

Event Description

The applier broke during surgery.The broken part fell into the patient and it was retrieved.The patient's condition was reported as fine.

• Brand Name: HOL ML 5MM 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: 5915723
• MDR Text Key: 53526530
• Report Number: 3011137372-2016-00237
• 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: 08/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 544965
• Device Lot Number: 06B1629318-0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2016
• Was Device Evaluated by Manufacturer?: No
• 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