MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG FOREIGN BODY FORCEPS; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED

Model Number 27071TJ

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 11/20/2020

Event Type  malfunction  

Event Description

Three (3) fr alligator cyst grasper broke during first attempt to grasp a ureteral stent.The piece of jaw that broke off was retrieved and removed from the patient.Device purchased in (b)(6) 2020, remains under 1-year warranty.

Event Description

Three (3) fr alligator cyst grasper broke during first attempt to grasp a ureteral stent.The piece of jaw that broke off was retrieved and removed from the patient.Device purchased in (b)(6) 2020, remains under 1-year warranty.

• Brand Name: FOREIGN BODY FORCEPS
• Type of Device: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG; 2151 e. grand avenue; el segundo CA 90245
• MDR Report Key: 10934667
• MDR Text Key: 219155336
• Report Number: 10934667
• Device Sequence Number: 1
• Product Code: OCZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27071TJ
• Device Lot Number: OP 01
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/25/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/02/2020
• Patient Sequence Number: 1