MAUDE Adverse Event Report: KARL STORZ SE & CO. KG UNIDRIVE S III MOTOR SYSTEM

Model Number	20701020-1
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the "footpedal and morcellator unable to work with unidrive, tested with 3 different morcellators but still has e09 error code.The customer rang whilst they were in a procedure and after advising to use another morcellator to see if the issue persists, she called back confirming the issue is still there and they had to cancel the case.
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
"one-pedal footswitch, analog, two-stage" with material number 20016230 was returned to karl storz tuttlingen on december 9, 2024.Material 27702050 and the leading material 20701020-1 were not returned yet.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The customer reports the following: (b)(6) from the above rang reporting an issue with their unidrive s iii system.Footpedal and morcellator unable to work with unidrive, tested with 3 different morcellators but still has e09 error code.The customer rang whilst they were in a procedure and after advising to use another morcellator to see if the issue persists, she called back confirming the issue is still there and they had to cancel the case.Only (b)(6) one-pedal footswitch, analog, two-stage was sent in for investigation.During the test, it was determined that the switching point of the pedal was slightly outside the specified tolerance in accordance with the test criteria from the test instructions (c4.2.0001.Wi5631790-paw).Testing was also carried out in the application in a set with the unidrive s iii motor system test devices and the drill cut x ii.However, an error message as specified by the customer (error code e09) could not be reproduced in the application.According to the product description, the error message (e09) refers to the handpiece, which must be faulty.It cannot be ruled out that the unidrive s iii motor system unit has an internal defect.No most probable cause can be given for the unidrive s iii system and the drillcut x ii handpiece that were not sent in.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: UNIDRIVE S III MOTOR SYSTEM
• Common Device Name: UNIDRIVE S III MOTOR SYSTEM
• 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: 20868470
• Report Number: 9610617-2024-00496
• Device Sequence Number: 15596949
• Product Code: HIH
• UDI-Device Identifier: 04048551278802
• UDI-Public: 04048551278802
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K223520
• 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): 02/03/2025

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: 20701020-1
• Device Catalogue Number: 20701020-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2024
• Supplement Date Received by Manufacturer: 12/09/2024; 01/29/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 01/02/2025; 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MATERIAL: 20016230, SN: (B)(6).; MATERIAL: 27702050, SN: (B)(6).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown