MAUDE Adverse Event Report: AESCULAP, INC. ATRAUMATIC GRASPER; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number M49435

Device Problems Break (1069); Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/07/2020

Event Type  malfunction  

Event Description

Surgeon unable to close jaws of davis and geck grasper.Gasper then broke inside patient.8mm trocar was placed and two small pieces were retrieved.

• Brand Name: ATRAUMATIC GRASPER
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): AESCULAP, INC.; 3773 corporate pkwy; center valley PA 18034
• MDR Report Key: 9902616
• MDR Text Key: 185708912
• Report Number: 9902616
• Device Sequence Number: 1
• Product Code: GCJ
• 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: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M49435
• 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: 03/12/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 11315 DA