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

Catalog Number PGCC300

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/25/2023

Event Type  malfunction  

Event 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".

Manufacturer Narrative

(b)(4).

Event 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".

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
• Type of Device: 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
• MDR Text Key: 328499907
• Report Number: 3011137372-2023-00241
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 14026704582614
• UDI-Public: 14026704582614
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172775
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PGCC300
• Device Lot Number: GML-00421
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female