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

Catalog Number 544965

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The user tried to install a clip in the applier, but the clip came off the applier.A new applier was used as a result.The clip did not fall into the patient's body.There was no harm to the patient.

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) facility in june of 2015 as part of a 50 pc.Lot.The returned instrument was evaluated and found that the jaws were loose and the tips are slightly misaligned to each other in the closed position.Further evaluation showed that although the jaws are loose and tips are slightly misaligned in the closed position 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.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.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 other remarks: time.Per fda guidelines for manufacturers which state: "manufacturers are required to report to the fda when they learn that any of their devices may have caused or contributed to a death or serious injury.Manufacturers must also report to the fda when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur." this incident is not reportable at this time with the information provided.Results - no result code available that could accurately describe that the complaint was confirmed, but the root cause is unknown.

Event Description

The user tried to install a clip in the applier, but the clip came off the applier.A new applier was used as a result.The clip did not fall into the patient's body.There was no harm to the patient.

• 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: 6124752
• MDR Text Key: 60856485
• Report Number: 3011137372-2016-00341
• 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: 11/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• 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: 06B1514048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2017
• 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