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

Catalog Number 544965

Device Problems Separation Failure (2547); Difficult to Open or Close (2921)

Patient Problem No Information (3190)

Event Date 07/09/2018

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 the clip applier was used during laparoscopy cholecystectomy.After locking the clip around the vessel, the jaws of the applier remained closed and would not release.The patient's condition is unknown at this time.

Manufacturer Narrative

(b)(4).The dhr for the returned instrument was reviewed and found completely without any irregularities.This instrument was manufactured at the (b)(4) as part of a 50 pc.Lot in (b)(6) of 2017.The returned instrument was evaluated as received and found that the handle to jaw mechanism was sluggish/binding and knob rotation mechanism was dry and sluggish feeling and the jaws would remain closed in multiple locations when closed thus we are able to validate this complaint.After the initial evaluation this instrument was properly lubricated and further evaluation showed that this instrument picks up, retains, closes and releases multiple clips as required of its function both with and without the use of silastic test tubing.Parts were 100% visually inspected and function tested at the (b)(4) 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.At this time it is un-determined what caused the alleged issue, but it is suspected that the customer did not "lubricate" the instrument prior to sterilization as recommended in ifu (l06109 r04) supplied with the instrument which states "the instrument must be cleaned, lubricated, functionally checked, and sterilized prior to each use.Use a non-silicone, water-based lubricant prior to sterilization." no corrective action required at this time.

Event Description

It was reported that the clip applier was used during laparoscopy cholecystectomy.After locking the clip around the vessel, the jaws of the applier remained closed and would not release.The patient's condition is unknown at this time.

• Brand Name: HOL ML 5 MILLIMETER 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: 7738603
• MDR Text Key: 115668396
• Report Number: 3011137372-2018-00222
• 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,Followup
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 544965
• Device Lot Number: 06H1638572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2018
• 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