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
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.
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 affected device has been requested for investigation by the manufacturer.Device was returned for investigation.
Additional Manufacturer Narrative
During investigation of the returned product (article 26168dm with lot xv01) a break was found at the distal end of the item.The article 26168dm consists of three parts, the anatomical blade of the special screw and the ceramic attachment.The ceramic attachment with the special screw is missing from the examined article.The item was manufactured in october 2014.It is likely that high age and the associated brittle material caused the article to break, possibly there was also incorrect handling which favoured the breakage through excessive force.Internal karl storz reference number: (b)(4).

• 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
• 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: 18624144
• Report Number: 9610617-2024-00026
• Device Sequence Number: 7668178
• Product Code: HIH
• UDI-Device Identifier: 04048551096154
• UDI-Public: 4048551096154
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K992027
• 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,Followup
• Report Date (Section B): 04/03/2024

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2024
• Supplement Date Received by Manufacturer: 01/26/2024; 03/26/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 03/04/2024; 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2014
• 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