MAUDE Adverse Event Report: KARL STORZ SE & CO. KG BETTOCCHI OUTER SHEATH; ENDOSCOPE SHEATH, REUSABLE

Model Number	26153BO
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.Internal karl storz reference number: (b)(4).
Event or Problem Description
It was reported that metal fragments and rust came off from the instruments while doing a hysteroscopy and polypectomy case.Some metal fragments were recovered, but some fragments could be still inside the patient.

• Brand Name: BETTOCCHI OUTER SHEATH
• Common Device Name: ENDOSCOPE SHEATH, REUSABLE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 17671448
• Report Number: 2020550-2023-00228
• Device Sequence Number: 15004715
• Product Code: HET
• UDI-Device Identifier: 04048551230176
• UDI-Public: 4048551230176
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2023
• Report Date (Section F): 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 26153BO
• Device Catalogue Number: 26153BO
• Device Lot Number: YU05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/31/2023
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/01/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/01/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 26159DHW - PUNCH, 5 FR., 34 CM / LOT-CODE: PU01; 26159SHW - SCISSORS, POINTED, 5 FR., 34 CM / LOT-C
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown