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	11/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that doctor found broken jaw after procedure, then it was removed well from patient and no patient harm reported.
Additional Manufacturer Narrative
(b)(4).The device investigation is pending and a follow-up report will be issued after the investigation is completed.Teleflex will continue to monitor and trend related events.
Additional Manufacturer Narrative
(b)(4).The device was returned and a broken jaw was confirmed.The lot number was not reported, so a dhr review was not possible.The complaint history was reviewed for the previous 24 months.There were no similar events reported.The cause for this event cannot be determined.
Event or Problem Description
It was reported that doctor found broken jaw after procedure, then it was removed well from patient and no patient harm reported.

• Brand Name: ALLIGATOR GRASPER
• Common Device Name: ENDOSCOPIC TISSUE APPROXIMATIO
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16039109
• Report Number: 3011137372-2022-00252
• Device Sequence Number: 20629192
• Product Code: OCW
• UDI-Device Identifier: 14026704640062
• UDI-Public: 14026704640062
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2022

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 Model Number: IPN914228
• Device Catalogue Number: GBC250
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2022
• Supplement Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 04/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown