MAUDE Adverse Event Report: TELEFLEX MEDICAL SURGICAL LAPAROSCOPIC GRASPER; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Device Problems Break (1069); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2020

Event Type  No Answer Provided  

Event Description

Instrument broke during surgery.X-ray confirmed no retained foreign objects.Grasper part of the device bent backwards - pulled out of trocar - would not fit back thru the trocar.Pulled everything out together then it broke.Bent inside of the patient.No harm to the patient.

• Brand Name: SURGICAL LAPAROSCOPIC GRASPER
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 9817551
• MDR Text Key: 182956109
• Report Number: 9817551
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/02/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/11/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 14965 DA