MAUDE Adverse Event Report: KARL STORZ SE & CO. KG SHAVER BLADE GYN

Model Number	26208SB
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The items in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that two new blades broke as soon as drill cut was started.In this case, it would have been possible for a piece of the blade to have ended up inside the patient.Fortunately, this did not happen when the blade was outside the patient when the piece came off.
Additional Manufacturer Narrative
In the case of the claimed article (b)(4) with the lot sn01 it was found during inspection that the inner blade jaw part is broken off.On the inside of the outer shaft a discoloration is visible, most likely caused by thermal damage.It is concluded that cooling was probably neglected here, which led to heat development and as a result the fracture occurred at the distal end.In the instructions for use of the article it is stated that insufficient irrigation and suction may lead to damage to the product, that irrigation and suction must be monitored and controlled throughout the entire procedure and to check the product for any blocked channels or damage.It is furthermore stated to check the product for functionality, damage and changes to the surface and to not overload the product with mechanical stress.Based on the damages found on the article, it is assumed that this is a case of non-compliance with the ifu/processing instructions.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: SHAVER BLADE GYN
• Common Device Name: SHAVER BLADE
• 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: 18519520
• Report Number: 9610617-2024-00008
• Device Sequence Number: 15148498
• Product Code: HIH
• UDI-Device Identifier: 04048551274736
• UDI-Public: 4048551274736
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K223520
• 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): 04/26/2024

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: 26208SB
• Device Catalogue Number: 26208SB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2023
• Supplement Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARTICLE: (B)(4) SERIAL: (B)(6).
• Patient Sex: Unknown