MAUDE Adverse Event Report: AESCULAP, INC BABCOCK GRASPER; FORCEPS

Device Problem Break (1069)

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

Event Date 06/10/2019

Event Type  malfunction  

Event Description

Physician was performing laparoscopic surgery using a laparoscopic babcock grasper.While working, tip to grasper broke and was in patient.Parts were removed and xray confirmed there were no retained pieces.

• Brand Name: BABCOCK GRASPER
• Type of Device: FORCEPS
• Manufacturer (Section D): AESCULAP, INC; 3773 corporate pkwy.; center valley PA 18034
• MDR Report Key: 8711580
• MDR Text Key: 148426927
• Report Number: 8711580
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/12/2019

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/12/2019
• Date Report to Manufacturer: 06/19/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26280 DA
• Patient Weight: 100