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

Model Number	IPN914232
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
It was reported that: the jaw of the device snapped mid hold and dislodged into patient.Broken jaw was recovered.
Event or Problem Description
It was reported that: the jaw of the device snapped mid hold and dislodged into patient.Broken jaw was recovered.
Additional Manufacturer Narrative
Qn# (b)(4).The returned device was received in accustomed state.The device was in a plastic bag with outer "disinfection tag".One side of the jaw was missing completely from the device.The broken jaw was sent back as well tapped to the bag.All parts on the device were intact and the device was tested and functional.The dhr could not be reviewed because the lot number is unknown.The cause of the broken device is undetermined.It is possible that the jaw of the device snapped due to a design flaw.This is outside the control of the manufacturer.The root cause is unknown, and no corrective actions are necessary currently.

• Brand Name: MINIGRIP CLUTCH 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: 16387000
• Report Number: 3011137372-2023-00017
• Device Sequence Number: 5694512
• Product Code: OCW
• UDI-Device Identifier: 14026704640116
• UDI-Public: 14026704640116
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 01/20/2023

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: IPN914232
• Device Catalogue Number: PGCC300
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2023
• Supplement Date Received by Manufacturer: 03/20/2023
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 03/20/2023
• 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