MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC. BLADDER URINARY STORZ MODEL 27074B OPTICAL STONE CRUSHING FORCEPS; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED

Device Problems Entrapment of Device (1212); Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/11/2021

Event Type  Injury  

Event Description

Tip of storz model 27074b optical stone crushing forceps was noted to have tip fragment break where actuator rod connects to the moveable jaw resulting in fragments of device that required manual removal from the patient's bladder.Fda safety report id # (b)(4).

• Brand Name: BLADDER URINARY STORZ MODEL 27074B OPTICAL STONE CRUSHING FORCEPS
• Type of Device: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA, INC.
• MDR Report Key: 12771129
• MDR Text Key: 280545421
• Report Number: MW5105156
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic
• Patient Race: Native Hawaiian Or Other Pacific Islander