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

Catalog Number 544965

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The clips fell from applier easily and some clips were dropped in the patient during the procedure.All the clips were retrieved.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).The dhr for the instrument in question, was reviewed and found completely without any irregularities.This instrument was manufactured (b)(4) in may of 2015.The returned instrument was evaluated and found that the jaws are aligned with each other and the tip set as received is correct per print specs.Further evaluation showed that this instrument picks up, retains, closes and releases clips both with and without the use of silastic test tubing as required of its function.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 (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 at this time.

Event Description

The clips fell from applier easily and some clips were dropped in the patient during the procedure.All the clips were 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: 5876328
• MDR Text Key: 52107344
• Report Number: 3011137372-2016-00225
• 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: 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2016
• 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: 06C1400239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2016
• 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