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
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).
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.

• 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
• MDR Report Key: 19645013
• Report Number: 2020550-2024-00193
• Device Sequence Number: 7479549
• Product Code: GEI
• UDI-Device Identifier: 04048551328750
• UDI-Public: 4048551328750
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 07/01/2024
• Report Date (Section F): 01/07/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/28/2024
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/07/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/01/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown