MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ANATOMICAL SHEET, MEDIUM; UTERINE ELEVATOR

Model Number	26168DM
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
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 the manipulator ring broke off and remained in the vagina.The patient passed the part on the toilet the next day.No negative impact in state of health reported.Nevertheless, the risk of internal injuries and infection must be taken into account as related to this incident.

• Brand Name: ANATOMICAL SHEET, MEDIUM
• Common Device Name: UTERINE ELEVATOR
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 18624143
• Report Number: 2020550-2024-00026
• Device Sequence Number: 12679629
• Product Code: HIH
• UDI-Device Identifier: 04048551096154
• UDI-Public: 4048551096154
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 02/01/2024
• Report Date (Section F): 02/01/2024

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: 26168DM
• Device Catalogue Number: 26168DM
• Device Lot Number: XV01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/31/2024
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/01/2024
• 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