MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK TAKEAPART ENDO ML APPLIER 20-DEG; APPLIER, SURGICAL, CLIP

Model Number IPN915189

Device Problem Separation Failure (2547)

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

Event Date 07/05/2021

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

Customer reported that on (b)(6) 2021, during a cholecystectomy, the hemolock applier remained blocked when the second clip was applied.So it was impossible to remove the applier.Clinical consequences: the use of a second device was necessary to release the jaws of the applier.The clip remained properly in place on the patient.The applier was used by an experienced user.

Event Description

Customer reported that on (b)(6) 2021, during a cholecystectomy, the hemolock applier remained blocked when the second clip was applied.So it was impossible to remove the applier.Clinical consequences: the use of a second device was necessary to release the jaws of the applier.The clip remained properly in place on the patient.The applier was used by an experienced user.

Manufacturer Narrative

Qn#(b)(4).The dhr for the returned instrument was reviewed and found completely without any irregularities.This instrument was produced at the teleflex medical kenosha, wi facility as part of a 25-piece lot in june of 2011.Evaluation of the returned instrument shows that it has been repaired prior to the alleged defect since it has additional lot coding on the g00436m handle and its overall finish is shiny and polished and not as originally produced as a glass bead finish.We suspect that the original laser marking was taped over prior to polishing operation at rework vendor since it is duller and appears as a worn glass bead finish.Functional testing of this instrument shows that it is able to pick-up, retain, close and release multiple clips with and without the use of silastic test tubing.We were unable to replicate the alleged issue therefore we are unable to validate this complaint.We are unable to determine what caused the alleged issue since we were unable to replicate it.All 25 pieces from this lot were 100% visually inspected and function tested prior to shipment to the customer as this was a standardized procedure at that 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.

• Brand Name: HEMOLOK TAKEAPART ENDO ML APPLIER 20-DEG
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 12202339
• MDR Text Key: 262669966
• Report Number: 3011137372-2021-00193
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 24026704696813
• UDI-Public: 24026704696813
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• 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: 06H1031913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Date Manufacturer Received: 09/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1