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

Model Number	IPN914229
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that while in use during a laparoscopic cholecystectomy, "the jaw at the end of the device broke off into the patient during procedure.Surgeon had to fish out broken piece".No patient harm or injury.The patient status is reported as "fine".Additional information received states that "all pieces were removed successfully.The device was removed from the patient and placed to the side to be investigated".Per the customer it is unknown if a new applier was used to complete the procedure.
Additional Manufacturer Narrative
(b)(4).The complaint sample was returned.Grace manufacturing, the manufacturing site reported " the returned device was received by the quality department.The device was in a plastic bag with outer "disinfection tag".One side of the jaw was broken completely off.The broken jaw piece was tapped separately inside of the bag.All other parts were intact.No manufacturing flaws were observed.The dhr was reviewed by qa.All operations and documentation were completed and acceptable.The root cause of the damaged device is undetermined.It is likely the device was damaged due to excessive force or incorrectly arming the device before inserting or guiding through the body.It is possible that the user did not fully arm the device and attempted to insert the device with the jaws exposed (not safely behind the needle point)." teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that while in use during a laparoscopic cholecystectomy, "the jaw at the end of the device broke off into the patient during procedure.Surgeon had to fish out broken piece".No patient harm or injury.The patient status is reported as "fine".Additional information received states that "all pieces were removed successfully.The device was removed from the patient and placed to the side to be investigated".Per the customer it is unknown if a new applier was used to complete the procedure.

• Brand Name: MINIGRIP 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17100745
• Report Number: 3011137372-2023-00158
• Device Sequence Number: 15407045
• Product Code: OCW
• UDI-Device Identifier: 14026704640086
• UDI-Public: 14026704640086
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K172775
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2023

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: IPN914229
• Device Catalogue Number: PGAC300
• Device Lot Number: GML-00379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2023
• Supplement Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown