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

Catalog Number 544990

Device Problems Positioning Failure (1158); Separation Failure (2547)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/18/2017

Event Type  Injury  

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

It was reported that the applier did not release some clips during ligation of vessel.The clips were finally released, but after that, vessel injury was confirmed so hemostasis therapy and blood transfusion were needed.The patient's condition is unknown at this time.

Manufacturer Narrative

(b)(4).The dhr for the instrument in question, was reviewed and found completely without any irregularities.This instruments was manufactured at the tecomet, inc kenosha facility as part of a 50pc.Lot in (b)(6) 2015.Evaluation of the returned instrument showed that the jaws of this instrument are aligned properly and it functions normally.Further evaluation of this instrument shows that this instrument picks-up, retains, closes and releases clips as required of its function both with and without the use of silastic test tubing.We are unable to validate the alleged complaint since we are unable to duplicate the alleged issue.Parts were 100% visually inspected and tested at the tecomet inc.Kenosha 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 un-determined what caused the alleged defect.

Event Description

It was reported that the applier did not release some clips during ligation of vessel.The clips were finally released, but after that, vessel injury was confirmed so hemostasis therapy and blood transfusion were needed.The patient's condition is unknown 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: 6569031
• MDR Text Key: 75239481
• Report Number: 3011137372-2017-00171
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 544990
• Device Lot Number: 06A1496920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2017
• 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
• Patient Outcome(s): Required Intervention