MAUDE Adverse Event Report: TELEFLEX MEDICAL HOL ML 5 MILLIMETER 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 07/04/2017

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

Reported issue: the applier was not releasing properly during a procedure.Additional information indicates that the applier failed to release the clip.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 (b)(4) as part of a 50pc.Lot in march of 2016.The returned instrument was evaluated and found that the knob rotation and handle to jaw mechanisms were both dry and sluggish feeling signifying that this instrument is in need of proper lubrication.Further evaluation showed that when attempting to close a clip to verify function, the jaw mechanism bound up after clip was released thus we are able to validate the alleged complaint.Parts were 100% visually inspected and tested at the (b)(4) before instruments were sent to the 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 suspected that this instrument was not lubricated prior to sterilization at the customer's facility as instructed in ifu l6109 r.04 which was supplied with the instrument at the time of manufacture which states "appropriate care, cleaning, lubrication and maintenance are important to ensure proper function." after initial investigation this instrument was properly other remarks: lubricated as instructed in ifu 6109 r.04 and proper smooth function to all of its mechanisms was restored.No corrective action required at this time.

Event Description

Reported issue: the applier was not releasing properly during a procedure.Additional information indicates that the applier failed to release the clip.There was no patient injury.

• 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: 6997119
• MDR Text Key: 91337468
• Report Number: 3011137372-2017-00349
• 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: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 544965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2017
• 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