MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH F. RESECT. SHEATH, 15 FR.; RIGID ENDOSCOPE SHEATH, REUSABLE

Model Number	26055CB
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As per manufacturer incident report #(b)(4) received from the factory in germany: the reported event happened in spain.According to the information available, the ceramic tip broke off inside the patient, with a kind of explosion.The physician had to remove the parts from inside the patient without being sure that all parts were collected.There is no further information related to the described explosion.
Additional Manufacturer Narrative
The initial review of the instruments received for analysis does not show signs of explosion; thermal damages and abrasion are visible on the instruments.Investigation is ongoing.
Additional Manufacturer Narrative
The explosion/bang described by the user can only have been caused by the damaged ceramic insert.The investigation showed that the ceramic was damaged by excessive force application.In the course of the missing insulation between the optics and the inner shaft surface, a short circuit subsequently occurred.The distal end shows thermal damage and the ceramic insert is completely broken due to excessive force application.

• Brand Name: INNER SHEATH F. RESECT. SHEATH, 15 FR.
• Common Device Name: RIGID ENDOSCOPE SHEATH, REUSABLE
• 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: anja fair ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 14685225
• Report Number: 9610617-2022-00090
• Device Sequence Number: 6636957
• Product Code: HIH
• UDI-Device Identifier: 04048551275597
• UDI-Public: 4048551275597
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K882270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2022

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: 26055CB
• Device Catalogue Number: 26055CB
• Device Lot Number: RO01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2022
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 06/14/2022
• Supplement Report FDA Received Date: 07/12/2022
• Date Device Manufactured: 04/15/2021
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown