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

Model Number UP210

Device Problem Pumping Stopped (1503)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/12/2023

Event Type  Injury  

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 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.

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).

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
• Type of Device: 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
• MDR Text Key: 316000115
• Report Number: 9610617-2023-00111
• Device Sequence Number: 1
• Product Code: HIG
• UDI-Device Identifier: 04048551376041
• UDI-Public: 4048551376041
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K180735
• 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: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/20/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention