MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC STORZ; RESECTOSCOPE

Lot Number LOT XQ05

Device Problems Break (1069); Thermal Decomposition of Device (1071)

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

Event Date 12/24/2020

Event Type  malfunction  

Event Description

Patient had a cystoscopy turp for bph.After procedure, the scrub tech noticed the ceramic inner sheath of the resectoscope was chipped off.Informed physician and x-ray x 2 were done in the operating room.Physician was not able to visualize any pieces of the chipped inner sheath possibly left inside the patient.It was discovered that the outer sheath was burned by the electrical loops used for the case.Fda safety report id # (b)(4).

• Brand Name: STORZ
• Type of Device: RESECTOSCOPE
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA, INC; el segundo CA 90245
• MDR Report Key: 11125289
• MDR Text Key: 225573794
• Report Number: MW5098690
• Device Sequence Number: 1
• Product Code: FJL
• Combination Product (y/n): Y
• 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: 01/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: LOT XQ05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/05/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR