MAUDE Adverse Event Report: TELEFLEX MEDICAL HOL L 10MM ENDO APPLIER; 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 04/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The original reports were submitted on time and accepted.This report is re-submitted due to an fda request to submit report with the corrected mdr number.The correct mdr number for this report is 3011137372-2016-00208.The device history review for the instrument in question, was reviewed and found complete without any irregularities.This instrument was manufactured at the (b)(4) facility as part of a 50-piece lot in (b)(6) of 2016.The returned instrument was evaluated and found that the jaws are aligned properly and both the closed and open jaw dimensions measured to print specifications and 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.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.We are unable to validate the alleged complaint since we were unable to replicate the alleged condition.No corrective action required at this time.The root cause is unknown.Teleflex will continue to monitor and trend related events.

Event Description

The clips were staying in the applier after application to the vessel and clips fell into the patient which was retrieved.The patient's condition was reported as fine.

• Brand Name: HOL L 10MM ENDO APPLIER
• Type of Device: APPLIER,SURGICAL, CLIP
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 5772324
• MDR Text Key: 188654437
• Report Number: 3011137372-2016-00208
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2016
• 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: 06K1525304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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