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

Model Number IPN915189

Device Problem Difficult to Open or Close (2921)

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

Event Date 03/14/2023

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

Reported issue: the user was unable to open/close the handle because of a protrusion on the screw of the handle during the pretest.The applier was sent to our technical specialist, who confirmed that the screw of the handle was detached.

Manufacturer Narrative

(b)(4).The device was returned and sent to the manufacturing site (tecomet) for investigation.Tecomet reports: "the dhr for the alleged defective instrument was reviewed and found complete without any irregularities.The alleged defective instrument was produced at the tecomet, inc.Kenosha, wi facility as part of a (b)(4).Lot in march of 2022.It was found that this order was made from the correct materials and components and all approved processes were followed.Evaluation of the returned device as received shows that the jaws are loose and misaligned to each other and not engaged to the drive rod mechanism and the handles are actuated in the closed position and the handle pivot screw is backed out of its threads and sticking out of one side of the proximal handle.There is no visible damage to the jaw pivot pin area of the outer tube assembly.After the initial evaluation this instrument was dis-assembled in order to evaluate its internal components and it was found that the inner drive rod bosses are both damaged where they engage the jaws.We suspect that the damaged drive rod bosses caused the jaws to become slightly loose and misaligned in the closed position.We are unable to determine what caused the drive rod bosses to become damaged and for the handle pivot screw to become loose and for the jaw to drive rod mechanism to become disengaged and for the handles to be stuck in the closed position but lack of proper maintenance and mishandling of this device 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

Reported issue: "the user was unable to open/close the handle because of a protrusion on the screw of the handle during the pretest.The applier was sent to our technical specialist, who confirmed that the screw of the handle was detached.".

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 16718832
• MDR Text Key: 313122966
• Report Number: 3011137372-2023-00083
• 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,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• 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: 06A2244656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.