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

Model Number 33121

Device Problems Break (1069); Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 09/08/2016

Event Type  Injury  

Event Description

Caregivers reported that during the patient's surgical procedure the surgeon was using a karl storz bowel grasper when one of the jaws on the device broke off inside the patient.The surgeon was immediately aware of the issue.The surgeon continued with the procedure and chose to wait until after the key parts of the procedure before ordering a x-ray and then removing the broken jaw.

• Brand Name: KARL STORZ LAPRASCOPIC BOWEL GRASPER
• Type of Device: LAPAROSCOPIC GRASPER
• Manufacturer (Section D): KARL STORZ; el segundo CA
• MDR Report Key: 6020886
• MDR Text Key: 57273354
• Report Number: 6020886
• Device Sequence Number: 1
• Product Code: PMU
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 33121
• 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: 09/21/2016
• Distributor Facility Aware Date: 09/08/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/21/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 107