MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY - AMERICA, INC. KARL STORZ; BOWEL GRASPER / LAPAROSCOPIC GENERAL AND PLASTIC

Catalog Number 33310C

Device Problem Break (1069)

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

Event Date 08/01/2018

Event Type  malfunction  

Event Description

During the procedure, the laparoscopic instrument (karl storz bowel grasper) was being used inside the pt when it was noticed that half of the jaw had broken in half.It was immediately removed from the pt's cavity in its entirety.The broken piece was removed intact and the cavity was assessed by the attending physician and it was confirmed that no pieces were left behind.

• Brand Name: KARL STORZ
• Type of Device: BOWEL GRASPER / LAPAROSCOPIC GENERAL AND PLASTIC
• Manufacturer (Section D): KARL STORZ ENDOSCOPY - AMERICA, INC.
• MDR Report Key: 7772144
• MDR Text Key: 116911837
• Report Number: MW5079029
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/08/2018

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: No Information
• Device Catalogue Number: 33310C
• Device Lot Number: OX09
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR