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

Catalog Number	PGAC300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The report states that during a laparoscopic cholecystectomy, the "grasper of the device broke off inside the patient while retracting the gallbladder.Broken piece was removed".No patient ham or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
(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 the plastic bag with an outer 'disinfection tag".Part was found to have one jaw broken and the other jaw remaining.All other parts were intact.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 damaged device is undetermined.The device likely could be 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.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.
Event or Problem Description
The report states that during a laparoscopic cholecystectomy, the "grasper of the device broke off inside the patient while retracting the gallbladder.Broken piece was removed".No patient ham or injury.The patient status is reported as "fine".

• 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: 18346800
• Report Number: 3011137372-2023-00259
• Device Sequence Number: 5674116
• Product Code: OCW
• UDI-Device Identifier: 14026704582607
• UDI-Public: 14026704582607
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2023

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 Catalogue Number: PGAC300
• Device Lot Number: GML-00409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2023
• Supplement Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2023
• 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