MAUDE Adverse Event Report: KARL STORZ SE & CO. KG STONE CRUSHING FORCEPS, SGL. ACTION JAWS

Model Number 27074B

Device Problem Difficult to Open or Close (2921)

Patient Problem Insufficient Information (4580)

Event Date 11/29/2023

Event Type  Injury  

Manufacturer Narrative

The reported device is pending to return for evaluation.Once the reported device is returned and evaluation is completed, a supplemental report would be made to the fda.This complaint will be tracked and trended.The event is filed under internal karl storz complaint id: (b)(4).

Event Description

It was reported that the stone crushing forceps' tip would not close during cystoscopy and cystolithopaxy procedures.During the procedure, the surgeon attempted to remove bladder stone by using stone crushing forceps; however, the forceps malfunctioned while inside the patient.The surgeon could not remove the forceps safely from inside of the patient; thus, aperineal urethrotomy in the penile urethra was performed to remove the forceps.It was noted that there was no issue with the forceps prior.The bladder stone did not require to utilize more forces than usual to crush.It was confirmed nothing was left inside of the patient.

• Brand Name: STONE CRUSHING FORCEPS, SGL. ACTION JAWS
• Type of Device: STONE CRUSHING FORCEPS, SGL. ACTION JAWS
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 18722589
• MDR Text Key: 335595892
• Report Number: 2020550-2024-00039
• Device Sequence Number: 1
• Product Code: OCZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27074B
• Device Catalogue Number: 27074B
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/24/2024
• Event Location: Hospital
• Date Report to Manufacturer: 02/16/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 120 KG