MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ENDOMAT LC PUMP FOR SUCTION ONLY; SUCTION PUMP

Model Number	20330320-1
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	10/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The unit was not returned for evaluation.It has been in use at this facility for over 5 years.The assembly of the tubing is described in detail with pictures in the ifu, and it is mandatory to remove air from the tubing and test for proper functioning; this evidently did not happen, otherwise, the mistake would have been noticed.In addition, the pump tube connectors have different widths (wide for outflow, narrow for inflow) so the pump tube can be inserted in one direction only; the pump head, where the tubing goes in, also has an arrow indicating the direction of the flow.
Event or Problem Description
Allegedly, approximately 2/3 of the way into a turp procedure, the endomat suction pump was hooked up; however, the pump tubing was placed incorrectly into the pump, resulting in the fluid inside the cannister to be pumped back into the patient's bladder.This caused over-distension, increased pressure, and fluid retention.Post-op, the patient was kept in icu for a longer time than planned to monitor the fluid retention condition.The patient has been released, and hospital confirmed there is no long-term impact to the patient.

• Brand Name: ENDOMAT LC PUMP FOR SUCTION ONLY
• Common Device Name: SUCTION PUMP
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 9329203
• Report Number: 9610617-2019-00108
• Device Sequence Number: 2484027
• Product Code: OCX
• UDI-Device Identifier: 04048551066423
• UDI-Public: 4048551066423
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K031457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/05/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: 20330320-1
• Device Catalogue Number: 20330320-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2019
• Initial Report FDA Received Date: 11/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR