MAUDE Adverse Event Report: TELEFLEX MEDICAL ALLIGATOR GRASPER; ENDOSCOPIC TISSUE APPROXIMATIO

Model Number IPN914228

Device Problem Break (1069)

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

Event Date 06/16/2021

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

On (b)(6) 2021 dr (b)(6) was doing a lap chole using the mini grasper when both insert alligator tips fell.No patient injury and they just grabbed another one to complete the case.I have the grasper in a bag at my desk.The grasper tips fell inside the patient but were safely retrieved and they both fell from the same handle.

Event Description

On (b)(6) 2021 dr (b)(6) was doing a lap chole using the mini grasper when both insert alligator tips fell.No patient injury and they just grabbed another one to complete the case.I have the grasper in a bag at my desk.The grasper tips fell inside the patient but were safely retrieved and they both fell from the same handle.

Manufacturer Narrative

(b)(4).In response to teleflex complaint (b)(4), and the subject gbc250, lot mlml-000586, the lot device history record for the subject device was reviewed along with the gbc250 complaint history, and there was no indication of a problem that could be attributed to the reported event.Upon review of the complaint description which states ".Broken needle tip." we were not able to confirm the reported event.The subject device was not available for review.Based upon the complaint history and our internal acceptance records , we cannot substantiate the reported event.

• Brand Name: ALLIGATOR GRASPER
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATIO
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 12134850
• MDR Text Key: 260516877
• Report Number: 3011137372-2021-00179
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 14026704640062
• UDI-Public: 14026704640062
• Combination Product (y/n): N
• PMA/PMN Number: K172775
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2022
• Device Model Number: IPN914228
• Device Catalogue Number: GBC250
• Device Lot Number: ML-000586
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1