MAUDE Adverse Event Report: KARL STORZ SE & CO. KG WORKING ELEMENT; RIGID ENDOSCOPE WORKING GUIDE

Model Number	26050E
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had burns on the introitus vaginae (vestibulum) and an additional medical intervention was required.Additional patient information is not available.
Additional Manufacturer Narrative
The item 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).

• Brand Name: WORKING ELEMENT
• Common Device Name: RIGID ENDOSCOPE WORKING GUIDE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 16487179
• Report Number: 2020550-2023-00052
• Device Sequence Number: 12224539
• Product Code: HIH
• UDI-Device Identifier: 04048551092293
• UDI-Public: 4048551092293
• 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): 03/06/2023
• Report Date (Section F): 03/02/2023

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: 26050E
• Device Catalogue Number: 26050E
• Device Lot Number: NP01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/02/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2023
• 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: ZC_200948426: MATERIAL-NO: 26050NK, LOT-NO: P001; ZC_200948441: MATERIAL-NO: 26050NK, LOT-NO: Z001; ZC_200948444: MATERIAL-NO: 277, LOT.NO: RQ01
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown