MAUDE Adverse Event Report: KARL STORZ SE & CO. KG KARL STORZ CYSTOSCOPE; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 27040XA

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/26/2024

Event Type  malfunction  

Event Description

Tip of cystoscope sheath broke off inside patient while operating.The broken piece was removed and the scope was taken off the field and replaced.No patient injury.

• Brand Name: KARL STORZ CYSTOSCOPE
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): KARL STORZ SE & CO. KG
• MDR Report Key: 19070533
• MDR Text Key: 339857238
• Report Number: MW5153648
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27040XA
• Device Lot Number: XO08
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White