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

Model Number 8360-10

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 06/14/2017

Event Type  malfunction  

Event Description

Surgeon was preforming a laparoscopic cholecystectomy when the laparoscopic grasper broke.Hinge separated from instrument and was able to be retrieved.Per report, no excessive pressure added to device.

• Brand Name: AESCULAP PRESTIGE
• Type of Device: LAPAROSCOPIC ACCESSORIES, GRASPER
• Manufacturer (Section D): AESCULAP, INC.; 3773 corporate pkwy.; center valley PA 18034
• MDR Report Key: 6646127
• MDR Text Key: 77713551
• Report Number: 6646127
• Device Sequence Number: 1
• Product Code: NWV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/14/2017

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: Physician
• Device Model Number: 8360-10
• Device Catalogue Number: 8360-10
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/14/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/14/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES