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

Model Number IPN915189

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/09/2022

Event Type  malfunction  

Event Description

The screw on the handle was found loose during the pretest before use.

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.

Manufacturer Narrative

(b)(4).The dhr for the returned instrument was reviewed and found completely manufacturing facility as part of a 50 pc.Lot in july of 2021.It was found that this order was made from the correct materials and components and all approved processes were followed.It can then be stated that the alleged non-conformance inciting this complaint was not due to an error in the manufacturing process.Evaluation of the returned instrument as received shows that the distal handle is loose and separate from the instrument in the bag and the pivot screw that holds the distal handle into the handle assembly is missing.We are able to validate this complaint.Further evaluation shows that the back side of the proximal handle shows evidence of staking in 3 places around the threaded hole.Per ifu, which was included with this instrument at time of manufacture "as screws may become loose during normal operation of an instrument, inspect before and after use in order to ensure proper function." we are unable to determine what caused the screw to become loose and missing but mishandling and lack of proper maintenance at the end user's facility is suspected.All 50 instruments from this lot were 100% visually inspected and function tested prior to shipment to the customer as this is a standardized procedure at this facility for this product line.Due to these findings, no further actions will be taken in response to this complaint and this record will be deemed closed.

Event Description

The screw on the handle was found loose during the pretest before use.

• Brand Name: HOL ML 5MM ENDO APPLIER
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville 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: 15278382
• MDR Text Key: 305154715
• Report Number: 3011137372-2022-00178
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 24026704696813
• UDI-Public: 24026704696813
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN915189
• Device Catalogue Number: 544965
• Device Lot Number: 06E2002051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2022
• 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: A
• Patient Sequence Number: 1