MAUDE Adverse Event Report: TELEFLEX MEDICAL HOL L 10MM ENDO APPLIER; APPLIER, SURGICAL, CLIP

Catalog Number 544995

Device Problems Premature Activation (1484); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/07/2018

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 physician tried to place the clip inside the patient's cavity and suddenly the applier got disarmed between the handle and the axle.In consequence the clip deployed inside the patient and the physician needed to remove the clip with another applier.

Manufacturer Narrative

(b)(4).The dhr for the alleged 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 2016.The returned instrument was evaluated and found that jaws are aligned but the knob and tube assembly move freely back and forth when the handle is squeezed indicating the snap ring which holds the knob & tube assembly to the handle assembly has been popped out of its groove thus validating the complaint.Parts were 100% visually inspected and function tested at the (b)(4) before instruments where 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.We are unable to determine how this instrument has been stored, handled or used by the end users facility.At this time it is undetermined as to what caused the snap ring which holds the knob & tube assembly to the handle assembly to be popped out of its groove but mishandling at the customers site is suspected.No corrective action required.

Event Description

It was reported that the physician tried to place the clip inside the patient's cavity and suddenly the applier got disarmed between the handle and the axle.In consequence the clip deployed inside the patient and the physician needed to remove the clip with another applier.

• Brand Name: HOL L 10MM 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: 7574699
• MDR Text Key: 110345336
• Report Number: 3011137372-2018-00133
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: EC
• 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: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 544995
• Device Lot Number: 06K1525301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2018
• 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