MAUDE Adverse Event Report: RICHARD WOLF GMBH WOLF LAPAROSCOPIC GRASPING FORCEPS; FORCEPS, GENERAL & PLASTIC SURGERY

Model Number 8642.65

Device Problem Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2020

Event Type  malfunction  

Event Description

Screw had fallen out of grasper during laparoscopic procedure.Grasper no longer works and was removed from patient.Screw was also removed from patient.No patient harm.

• Brand Name: WOLF LAPAROSCOPIC GRASPING FORCEPS
• Type of Device: FORCEPS, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): RICHARD WOLF GMBH; 353 corporate woods pkwy; vernon hills IL 60061
• MDR Report Key: 10232479
• MDR Text Key: 197563282
• Report Number: 10232479
• Device Sequence Number: 1
• Product Code: GEN
• 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: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8642.65
• 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: 07/01/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/06/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17520 DA