MAUDE Adverse Event Report: KARL STORZ KARL STORZ BOWEL GRASPER; BOWEL GRASPER / LAPAROSCOPIC BOWEL GRASPER

Catalog Number 33310C

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 07/03/2018

Event Type  malfunction  

Event Description

A portion of the bowel grasper broke and detached during surgery.The detached portion was retrieved.There was no pt harm.

• Brand Name: KARL STORZ BOWEL GRASPER
• Type of Device: BOWEL GRASPER / LAPAROSCOPIC BOWEL GRASPER
• Manufacturer (Section D): KARL STORZ ; GM
• MDR Report Key: 7784517
• MDR Text Key: 117309695
• Report Number: MW5079155
• Device Sequence Number: 1
• Product Code: OCZ
• 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: 08/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 33310C
• Device Lot Number: MH3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• 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