MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC. TUBE,INNER,CERAMIC INSULATION; CERAMIC INSULATION TUBE

Model Number 27040XA

Device Problem Mechanical Problem (1384)

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

Event Date 11/11/2022

Event Type  Injury  

Event Description

The event occurred in italy.It was reported that during the procedure the ceramic of the inner sheath of the resectoscope was fractured, and the fragment was brought back out of the uterine cavity.No negative impact on the state of health was reported.Internal karl storz reference number: (b)(4).

• Brand Name: TUBE,INNER,CERAMIC INSULATION
• Type of Device: CERAMIC INSULATION TUBE
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA, INC.; 2151 e grand ave; el segundo CA 90245 5017
• MDR Report Key: 15960193
• MDR Text Key: 305271901
• Report Number: 2020550-2022-00327
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551076521
• UDI-Public: 4048551076521
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/07/2022,12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27040XA
• Device Catalogue Number: 27040XA
• Device Lot Number: PR02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/07/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization