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

Catalog Number 544965

Device Problems Premature Activation (1484); Failure to Align (2522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2017

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

The complaint states: the jaws of applier were mis-aligned, so the applier was not able to hold clips properly and some clips came off.No clips fell in the patient.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 produced at the (b)(4) in (b)(6) of 2015 as part of a (b)(4).Lot.The returned instrument was evaluated and found that the tips are slightly misaligned to each other in the closed position and the jaw pivot pin is slightly popped out on one side of the tube assembly thus we are able to validate the alleged complaint.Also noted during the evaluation is that the instrument was returned with a non teleflex flush luer port cap and that the knob rotation and jaw mechanisms were dry and sluggish feeling signifying that this instrument is in need of proper lubrication.Further evaluation showed that although the tips are slightly misaligned and loose and the jaw pivot pin is slightly popped out on one side of the tube assembly that this instrument is able to pick up, retain, close and release clips both with and without the use of silastic tubing as required of its function.No corrective action required at this time.Parts were 100% visually inspected and 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 other remarks: standardized process for all instruments manufactured at this facility.At this time it is undetermined as to how the jaws became loose and slightly misaligned to each other but mishandling at the customer facility is suspected.No corrective action required at this time.Results - no result code available that could accurately describe that the complaint was confirmed, but the root cause is unknown.

Event Description

The complaint states: the jaws of applier were mis-aligned, so the applier was not able to hold clips properly and some clips came off.No clips fell in the patient.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: 6917118
• MDR Text Key: 89468502
• Report Number: 3011137372-2017-00300
• 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: 09/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• 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: 06B1514052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2017
• 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