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

Catalog Number 544965

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/20/2017

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

During 2nd clip ligation, the pin that holds the jaws loosened and popped, which made the grip of the jaws unstable.As a result of this issue, another applier was used instead and the procedure was finished without problems.There was no health injury reported and no clips fell in the patient.

Manufacturer Narrative

(b)(4).The dhr for the returned instrument was reviewed and found completely without any irregularities; this ins trument was produced at the tecomet, inc.Kenosha facility in (b)(6) 2015 as part of a 50 pc.Lot.The returned instrument was evaluated and found as received (1) of the jaws was missing and the other was still attached to the applier with the pin being slightly popped out of the other side of the bent tube.Further evaluation shows that the tube is flared/bent damaged at the jaw end and the jaw to handle mechanisms and knob rotation mechanisms were dry and sluggish.No corrective action required at this time.Parts were 100% visually inspected and tested at the tecomet, kenosha 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 cause the jaws to get loose and the tube end to be bent/damaged, but it is suspected that this instrument has been mishandled at the customers facility since there is evidence of damage to the tube at the jaw end it is also suspected that the customer did not "lubricate" the instrument other remarks: 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.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.

Event Description

During 2nd clip ligation, the pin that holds the jaws loosened and popped, which made the grip of the jaws unstable.As a result of this issue, another applier was used instead and the procedure was finished without problems.There was no health injury reported and no clips fell in 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: 6560220
• MDR Text Key: 74933158
• Report Number: 3011137372-2017-00154
• 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: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 544965
• Device Lot Number: 06B1514051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2017
• Initial Date FDA Received: 05/11/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/21/2017
• 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