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

Model Number IPN915189

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 06/01/2021

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

The jaws of the applier did not open/close properly during a pretest before use.Therefore, another unit was used instead.The applier was purchased by the hospital 9 months ago and had been used less than 10 times.

Manufacturer Narrative

Qn#(b)(4).The dhr for the returned instrument was reviewed and found completely without any irregularities.It was also found that this order was made from the correct materials and components.It can then be stated that the alleged non-conformance inciting this complaint was not due to an error in tecomet - kenosha's manufacturing process.This instrument was produced as part of a 50-piece lot in february of 2020.Evaluation of the returned instrument showed that the open tip dimension was undersized thus we are able to validate this complaint.Further evaluation shows that the jaws are slightly loose and misaligned in the closed position and the luer flush port was not tightened down fully.The luer flush port was removed and the outer tube assembly was rotated 360 and the flush port was re-installed and tightened down and the open jaw gap was re-measured and it now measures to teleflex print specifications of.280 +/-.025 at.295".After the evaluation this instrument was dis-assembled in order to evaluate its internal components and it was found that the inner drive rod (n00185) fingers are both damaged where they engage the jaws.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

The jaws of the applier did not open/close properly during a pretest before use.Therefore, another unit was used instead.The applier was purchased by the hospital 9 months ago and had been used less than 10 times.

• Brand Name: HOL ML 5MM ENDO APPLIER
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 12158934
• MDR Text Key: 261305443
• Report Number: 3011137372-2021-00180
• 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: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• 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: 06F1989605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Date Manufacturer Received: 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1