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

Model Number	IPN914228
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: ENDOSCOPIC TISSUE APPROXIMATIO
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 12134850
• Report Number: 3011137372-2021-00179
• Device Sequence Number: 4130980
• Product Code: OCW
• UDI-Device Identifier: 14026704640062
• UDI-Public: 14026704640062
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K172775
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 08/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1