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

Model Number	26153BO
Medical Device Problem Codes	Corroded (1131); 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.
Additional Manufacturer Narrative
The products were returned on 2023-09-07 and the investigation was completed on 2023-09-27.It was found that the returned articles have severe corrosion.This is probably related to the age of the items, as two of them were manufactured in 2015 and one in 2018, according to the lot, so the items are 8 and 5 years old.In addition, the article 26153bo was found to be bent in the area of the shaft and this shaft is no longer straight, which can have a negative effect on the mounted articles in the shaft or on the op.It was also found on article 26159dhw that the cutting edge of the scissors at the distal end of the scissor blade is damaged, making it difficult or impossible to cut.The same applies to item 26159dhw, where it can be seen that the cutting jaws are worn / damaged.According to the ifu, the function of these instruments should be checked for damage and corrosion etc.Before each use.The event is filed under internal karl storz complaint id: (b)(4).

• 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
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 17671449
• Report Number: 9610617-2023-00228
• Device Sequence Number: 17694205
• Product Code: HET
• UDI-Device Identifier: 04048551230176
• UDI-Public: 4048551230176
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K946359
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2023

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2023
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2015
• Is the Device Labeled for Single Use? (Y/N): No
• 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.; SCISSORS, POINTED, 5 FR., 34 CM / LOT-CODE: PR04.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown