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

Model Number 26055CB

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/05/2020

Event Type  malfunction  

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 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
• Type of Device: INNER RESECTOSCOPE SHEATH, 7MM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, ca ; 2188201
• MDR Report Key: 10314000
• MDR Text Key: 200068733
• Report Number: 9610617-2020-00083
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551275597
• UDI-Public: 4048551275597
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K882270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26055CB
• Device Catalogue Number: 26055CB
• Device Lot Number: SQ02
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention