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

Catalog Number 544990

Device Problem Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/26/2017

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

The applier was not able to hold clips properly.The clip did not fall in the patient's body or out of the body.No health injury was reported.

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 tecomet, inc.Kenosha facility as part of a 50pc.Lot in september of 2015.Since the instrument was not returned for evaluation we are unable to validate this complaint or determine root cause.All instruments are thoroughly inspected and function tested at time of manufacture.No corrective action required at this time.

Event Description

The applier was not able to hold clips properly.The clip did not fall in the patient's body or out of the body.No health injury was reported.

Manufacturer Narrative

(b)(4).The returned instrument was evaluated and it was found that the flush port cap was missing and the open jaw gap was undersized at.319" which is undersized to print specifications of.506"-.546".Further evaluation showed that this instrument is unable to load a clip as it was returned to us thus we are able to validate the alleged complaint.Parts were 100% visually inspected and tested at the tecomet, (b)(4) facility before instruments were sent to customer.No irregularities were found or reported at the time of processing and inspection of the product, as this is a standardized process for all instruments manufactured at this facility.At this time it is undetermined as to what caused this instrument to not function properly and for the open jaw gap to be undersized but it is suspected that the flush port has been removed and the tube assembly turned 360 and then the flush port re-installed at the customers facility.After further investigating the processes of manufacturing the instruments, all processes and procedures were followed.No corrective action required at this time.

Event Description

The applier was not able to hold clips properly.The clip did not fall in the patient's body or out of the body.No health injury was reported.

• 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: 6641142
• MDR Text Key: 77618354
• Report Number: 3011137372-2017-00209
• 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,Followup
• Report Date: 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• 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: 06A1496924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2017
• 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