MAUDE Adverse Event Report: TELEFLEX MEDICAL SURGICAL UNKNOWN DUMMY MATERIAL; APPLIER, SURGICAL, CLIP

Catalog Number 544995

Device Problems Activation, Positioning or Separation Problem (2906); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/27/2018

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 during use of hem-o-lok endo applier 10mm it was difficult to load the clip from the cartridge and the clips are not ligating properly during surgery.There was no patient injury.

Manufacturer Narrative

(b)(4).The dhr for the returned instrument was reviewed and found completely without any irregularities.This instrument was manufactured at the tecomet, inc.(b)(4) facility as part of a 50pc.Lot in february of 2016.The returned instrument was evaluated and found that as received the open jaw gap was undersized to print specifications.Further evaluation showed that this instrument as received was unable to load a clip thus we are able to validate this complaint.Further evaluation showed that the luer flush port was slightly loose and when removed it was found that it was gouged/damaged on its outer diameter signifying that it had been tampered with and possibly removed.After removal of luer port we rotated tube assy.360 and re-installed flush port and then re-measured the open jaw gap and it measured to print specifications.We are unable to determine how this instrument has been stored , handled and cleaned by the end users facility.Other remarks: parts were 100% visually inspected and tested at the tecomet, inc.(b)(4) facility before instruments were sent to customer.No irr egularities 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 suspected that this instrument has been tampered with at some time after leaving this facility in february of 2016.No corrective action required at this time.

Event Description

It was reported that during use of hem-o-lok endo applier 10mm it was difficult to load the clip from the cartridge and the clips are not ligating properly during surgery.There was no patient injury.

• Brand Name: SURGICAL UNKNOWN DUMMY MATERIAL
• 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: 7299234
• MDR Text Key: 101166360
• Report Number: 3011137372-2018-00067
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2018
• 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