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

Model Number 26168DM

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event 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.

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).

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was returned for investigation.

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
• Type of Device: 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
• MDR Text Key: 334334667
• Report Number: 9610617-2024-00026
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551096154
• UDI-Public: 4048551096154
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K992027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other