MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY - AMERICA, INC. SINGLE STEM RESECTOSCOPE

Model Number	CE0344
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/22/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The 5mm 24f rollerball was placed in the resectoscope by the surgeon.As he pulled it out from the resectoscope, the rollerball separated.The device didn't touch the pt.The device was placed in a red biohazard bag, then to be reported.A new 24f 5mm rollerball was given to the surgeon.Surgery resumed and pt remained safe throughout the procedure.

• Brand Name: SINGLE STEM RESECTOSCOPE
• Common Device Name: RESECTOSCOPE
• Manufacturer (Section D): KARL STORZ ENDOSCOPY - AMERICA, INC. ; 2151 e grand ave; el segundo CA 90245
• MDR Report Key: 8019115
• Report Number: MW5080906
• Device Sequence Number: 16442748
• Product Code: FJL
• UDI-Device Identifier: 08714729520528
• UDI-Public: 0108714729520528
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/26/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: CE0344
• Device Catalogue Number: M0068804010
• Device Lot Number: 0518023
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR