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

Catalog Number 544990

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/02/2017

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

During a laparoscopic appendectomy the doctor found the clip fell off the applier.There was no patient injury.

Manufacturer Narrative

(b)(4).The dhr for the lot number provided was reviewed and found completely without any irregularities.Lot no.06j1274433, complaint no.(b)(4) - this instrument was manufactured at the tecomet, inc.(b)(4) facility as part of a 50 piece lot in september of 2013.Evaluation of the returned instrument showed that this instrument picks up, retains, closes and releases clips both with and without the use of silastic test tubing as required of their function thus we are unable to validate the alleged complaint since we could not replicate the alleged issue.Parts were 100% visually inspected and tested at the tecomet, inc.(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.No corrective action required since we were unable to validate this complaint.

Event Description

During a laparoscopic appendectomy the doctor found the clip fell off the applier.There was no patient injury.

• 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: 6669680
• MDR Text Key: 78470611
• Report Number: 3011137372-2017-00220
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 544990
• Device Lot Number: 06J1274433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2017
• 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