MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INSERT,BOWEL GRASPER,FENESTRAT

Model Number 33310C

Device Problems Material Fragmentation (1261); Material Integrity Problem (2978)

Patient Problems Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)

Event Type  malfunction  

Manufacturer Narrative

The item has not returned at this time however, the device is almost 5 years old and breakage most likely is from mechanical stress overload.

Event Description

Allegedly, during the procedure, the jaws on the bowel grasper broke off and they were able to retrieve the jaws.X-ray was used to get the second piece.No patient injury reported just a delay due to the x-ray.

Manufacturer Narrative

The item was evaluated and found a slight bend in the shaft and the jaws are broken.Most likely cause is mechanical force.

• Brand Name: INSERT,BOWEL GRASPER,FENESTRAT
• Type of Device: BOWEL GRASPER
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen ; GM
• MDR Report Key: 11174321
• MDR Text Key: 230671144
• Report Number: 9610617-2021-00013
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04048551134092
• UDI-Public: 4048551134092
• Combination Product (y/n): N
• PMA/PMN Number: K935071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 33310C
• Device Lot Number: OU05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Date Manufacturer Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1