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

Catalog Number 544965

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/30/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the customer says when using the endo it clamped the vessel but did not release.They had to use another applier to pry it off.

Manufacturer Narrative

Qn#(b)(4).A device history record was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to 544965.Previous complaints for failure to release the clips were determined to be related to cleaning.(1) sample of 544965 lot 04b0900085-042 was received for evaluation.The device appears quite old and the rotation knob has faded in color.The jaws were examined under magnification and it was discovered that the forks which engage the tabs on the clip are bent out of proper shape.The upper and lower jaws are equally out of alignment and is consistent with a dropped instrument or similar striking impact from another instrument which occurred during use or cleaning.The actual root cause is unknown , but the deformed jaws prevent proper release of the clip once loaded in the jaws.The deformed jaws were not present at time of sale.This failure is directly related to maintenance , and or use.(1) sample of 544965 lot 04b0900085-042 was received for evaluation.The device appears quite old and the rotation knob has faded in color.The jaws were examined under magnification and it was discovered that the forks which engage the tabs on the clip are bent out of proper shape.The upper and lower jaws are equally out of alignment and is consistent with a dropped instrument or similar striking impact from another instrument which occurred during use or cleaning.The actual root cause is unknown , but the deformed jaws prevent proper release of the clip once loaded in the jaws.The device does not function as expected.The deformed jaws impact proper loading and release.A previous complaint is implicated in an open capa , but the root cause is unrelated confirmed complaints were received in this range with the same issue.A device history record was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to 544965.Previous complaints for failure to release the clips were determined to be related to cleaning.The deformed jaws were not present at time of sale.This failure is directly related to maintenance and or use.The sample will be retained.

Event Description

It was reported that the customer says when using the endo it clamped the vessel but did not release.They had to use another applier to pry it off.

• Brand Name: HOL ML 5 MILLIMETER ENDO APPLIER
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8772103
• MDR Text Key: 150422653
• Report Number: 3011137372-2019-00214
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 544965
• Device Lot Number: 04B0900085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Date Manufacturer Received: 08/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention