MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ROBI SCISSORS INSERT

Model Number	38610MW
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a loss of a ceramic inlay on a 38610mw post op was detected.The whereabouts of the ceramic inlay in the patient was confirmed by x-ray control.According to a telephone call, there are currently no plans to surgically remove the ceramic inlay.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The product was returned on 2024-07-03.The investigation of the product was completed on 2024-07-18.A visual inspection was carried out.It was observed on the scissor blade that the solder has been rinsed off, which could be an indication of the loosened bond of the ceramic.The instructions for use state that the chemical manufacturer's instructions regarding concentration, exposure time and standing time must be followed exactly.If they are not followed exactly, the ceramic inlay may have loosened as a result.In addition, the cutting edges of the scissor blades are damaged, which could indicate excessive force development.It can therefore be concluded that the most likely cause of the ceramic inlay falling out is user error.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ROBI SCISSORS INSERT
• Common Device Name: ROBI SCISSORS INSERT
• 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: 19645015
• Report Number: 9610617-2024-00193
• Device Sequence Number: 18012279
• Product Code: GEI
• UDI-Device Identifier: 04048551328750
• UDI-Public: 4048551328750
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K962030
• 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): 07/22/2024

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: 38610MW
• Device Catalogue Number: 38610MW
• Device Lot Number: YN02
• 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: 06/17/2024
• Supplement Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown