MAUDE Adverse Event Report: AESCULAP AG ADTEC SOVEREIGN; FORCEPS

Model Number PL232R

Device Problem Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2022

Event Type  malfunction  

Event Description

Pl232r atraumatic double action rotatable side lock laparoscopic wave graspers was opening while grasper handle was grasped closed during surgery in contact with the bowel.No injury was observed.Health care providers removed and replace the wave grasper with a new one.

• Brand Name: ADTEC SOVEREIGN
• Type of Device: FORCEPS
• Manufacturer (Section D): AESCULAP AG; 3773 corporate pkwy; center valley PA 18034
• MDR Report Key: 14266074
• MDR Text Key: 290538335
• Report Number: 14266074
• Device Sequence Number: 1
• Product Code: HTD
• 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: 04/15/2022

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 Model Number: PL232R
• Device Catalogue Number: PL232R
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/15/2022
• Date Report to Manufacturer: 05/03/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/03/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20440 DA