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

Model Number 8360-10

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 02/24/2021

Event Type  malfunction  

Event Description

Tip of the laparoscopic grasper broke.Fda safety report id # (b)(4).

• Brand Name: AESCULAP PRESTIGE GRASPER
• Type of Device: LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
• Manufacturer (Section D): AESCULAP ; center valley PA 18034
• MDR Report Key: 11462337
• MDR Text Key: 239447233
• Report Number: MW5099920
• Device Sequence Number: 1
• Product Code: NWV
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/08/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/10/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Weight: 60