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

Catalog Number	PGCC300
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "product bent during insertion which made it unusable".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "product bent during insertion which made it unusable".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).The complaint sample was not returned.Grace manufacturing, the manufacturing site reported: "no sample was available for testing.The dhr was reviewed.All operations and documentation were completed.The cause of the damaged device is undetermined.It is possible the device was mishandled and misused by the user resulting in a bent jaw.The root cause is unknown, and no corrective actions are necessary currently." teleflex will continue to monitor and trend for reports of this nature.

• 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: 18096964
• Report Number: 3011137372-2023-00241
• Device Sequence Number: 6061287
• Product Code: OCW
• UDI-Device Identifier: 14026704582614
• UDI-Public: 14026704582614
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 10/26/2023

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: PGCC300
• Device Lot Number: GML-00421
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2023
• Supplement Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Female