MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER RESECTOSCOPE SHEATH, 7MM

Model Number	26055CB
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As per the manufacturer's evaluation report: the neutral electrode of the cutting loop is broken off, insulation is melted, the cutting wire melted off; the break of the ceramic tip, as well as the welding point on the endoscope, are collateral damages following the damage of the cutting loop.The remaining electrode shows bending, and the resulting heat cracked the ceramic tip.
Event or Problem Description
As per a report we received from the factory in (b)(6) in regard to an incident that occurred in (b)(6): when surgeon was performing a tcr, at around three minutes, they found the cutting loop burning and the scope was damaged and the white ceramic of sheath also broken.An x-ray confirmed everything was retrieved; there was no harm to patient.

• Brand Name: INNER RESECTOSCOPE SHEATH, 7MM
• Common Device Name: INNER RESECTOSCOPE SHEATH, 7MM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 10314000
• Report Number: 9610617-2020-00083
• Device Sequence Number: 3542549
• Product Code: HIH
• UDI-Device Identifier: 04048551275597
• UDI-Public: 4048551275597
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K882270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/22/2020

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 Model Number: 26055CB
• Device Catalogue Number: 26055CB
• Device Lot Number: SQ02
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 07/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention