MAUDE Adverse Event Report: AESCULAP, INC. PRESTIGE ATRAUMATIC GRASPER; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Model Number 8360-10

Device Problems Break (1069); Fitting Problem (2183); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2020

Event Type  malfunction  

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 one instrument is an aesculap 8360-10 surgical laparoscopic prestige grasper.

• Brand Name: PRESTIGE ATRAUMATIC GRASPER
• Type of Device: LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
• Manufacturer (Section D): AESCULAP, INC.; 3773 corporate pkwy.; center valley PA 18034
• MDR Report Key: 9810690
• MDR Text Key: 182729369
• Report Number: 9810690
• Device Sequence Number: 1
• Product Code: NWV
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8360-10
• Device Catalogue Number: 8360-10
• 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: 03/10/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/10/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 14965 DA