MAUDE Adverse Event Report: TELEFLEX MEDICAL HOL L ENDO APPLIER 10MM 45CM; APPLIER, SURGICAL, CLIP

Catalog Number 544995L

Device Problems Bent (1059); Entrapment of Device (1212); Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/29/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The facility has communicated that the device is not available for evaluation.Teleflex will continue to monitor and trend related events.

Event Description

Per medwatch received: during the case, the blue wrapped clip applier malfunctioned, and was stuck on patient's vessel.The doctor had to assist with removal of the clip applier.Another clip applier was obtained with satisfactory results.Per rn in the case, the tip appeared to be bent causing the clip to be stuck on the vessel.We do not believe it was the clips, the instrument looked damaged.It was not noticed prior to the first use because it loaded without issues.The clip applier malfunctioned on the vessel and would not release.After the instrument was removed with the assistance of the surgeon's robotic arms it was inspected.The tip looked like it may have been misaligned or slightly bent on visual inspection.

Manufacturer Narrative

(b)(4).Since this instrument was not returned for evaluation and lot information has not been provided, we are unable to determine where and when it was produced or perform a thorough dhr review at this time.Since the instrument was not returned for evaluation and pictures were not provided we are unable to validate this complaint or determine root cause at this time.Per the information provided on notification summary it is suspected that this instrument might have been mishandled or damaged at the customers site.All instruments are thoroughly inspected and function tested at time of manufacture.

Event Description

Per medwatch received: during the case, the blue wrapped clip applier malfunctioned, and was stuck on patient's vessel.The doctor had to assist with removal of the clip applier.Another clip applier was obtained with satisfactory results.Per rn in the case, the tip appeared to be bent causing the clip to be stuck on the vessel.We do not believe it was the clips, the instrument looked damaged.It was not noticed prior to the first use because it loaded without issues.The clip applier malfunctioned on the vessel and would not release.After the instrument was removed with the assistance of the surgeon's robotic arms it was inspected.The tip looked like it may have been misaligned or slightly bent on visual inspection.

• Brand Name: HOL L ENDO APPLIER 10MM 45CM
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park 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: 6908242
• MDR Text Key: 89465569
• Report Number: 3011137372-2017-00294
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 544995L
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2017
• 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: N
• Patient Sequence Number: 1