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

Model Number	IPN914232
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).N/a other remarks: n/a corrected data: n/a.
Event or Problem Description
It was reported that "during the use of the grasper, the ratchet switch on the side broke off during a pediatric surgery.No clinical consequences for the staff or the patient".
Event or Problem Description
It was reported that "during the use of the grasper, the ratchet switch on the side broke off during a pediatric surgery.No clinical consequences for the staff or the patient".
Additional Manufacturer Narrative
Qn#(b)(4).The sample was returned to the manufacturer for investigation.The manufacturer, grace manufacturing, reported: "the returned device was received by the quality department.The device was in a plastic bag with the outer "disinfection tag".The device had one missing ratchet switch removed, but other component parts were intact.The device was still functional, and no manufacturing flaws were observed during investigation.The dhr was reviewed.All operations and documentation were completed, and no problems were found.The root cause of the ratchet switch detaching from the device is undetermined.It is possible that the ratchet switch detached due to a design flaw.This is outside the control of the manufacturer.The root cause is unknown, and no corrective actions are necessary at this time." teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a corrected data: n/a.

• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18465198
• Report Number: 3011137372-2024-00006
• Device Sequence Number: 19611714
• Product Code: OCW
• UDI-Device Identifier: 14026704582614
• UDI-Public: 14026704582614
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K172775
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2023

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: GML-00396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2023
• Supplement Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 01/16/2024
• 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