MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ENDOMAT SELECT; SURGICAL IRRIGATION/ASPIRATION PUMP

Model Number	UP210
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
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
The event occurred in (b)(6).It was reported that the stopcock on the sheath leaked during use and the pump stopped working during surgery.There was a prolongation of 1 hour and they had to convert to a mini-laparotomy (open surgery) to remove the prostate.
Additional Manufacturer Narrative
Additional information is provided in section d9 to reflect that the product was returned for evaluation.The item in question was returned to the manufacturer.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The stopcock on the sheath leaked during use and the pump stopped working during surgery.During product inspection of the returned products (one-pedal-footswitch and endomat select) no issue could be reproduced during testing.It is also concluded that the unreturned tubing set is not the cause of the reported error.However, the event log of the endomat select shows issues with the pressure (pressure deviations and high pressure) and afterwards issues with the pressure sensor offset calibration on the date of the incident.The affected endomat select was manufactured on 20.02.2019.It was in repair once in 2019 due to defective light guides.This has no influence on the reported problem.Due to the event log entries found, the most probable root cause is an issue with a defective pressure sensor membrane.This would lead to the logged events of very high pressure differences.It could also be possible that water entered the device and shorted some connections on the pressure sensor board, which then could have lead to the issues with the pressure offset adjustment.This is not visible.Based on the given facts we set the root cause to wearing.The event is filed under internal karl storz complaint id: (b)(4).File attachments: no files.

• Brand Name: ENDOMAT SELECT
• Common Device Name: SURGICAL IRRIGATION/ASPIRATION PUMP
• 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: 17004245
• Report Number: 9610617-2023-00111
• Device Sequence Number: 6296564
• Product Code: HIG
• UDI-Device Identifier: 04048551376041
• UDI-Public: 4048551376041
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K180735
• 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): 10/23/2023

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: UP210
• Device Catalogue Number: UP210
• 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: 05/15/2023
• Supplement Date Received by Manufacturer: 07/20/2023; 10/17/2023
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 07/21/2023; 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2019
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown