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

Model Number 20330320-1

Device Problem Misassembled (1398)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 10/01/2019

Event Type  Injury  

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 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
• Type of Device: SUCTION PUMP
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 9329203
• MDR Text Key: 166590503
• Report Number: 9610617-2019-00108
• Device Sequence Number: 1
• Product Code: OCX
• UDI-Device Identifier: 04048551066423
• UDI-Public: 4048551066423
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031457
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 20330320-1
• Device Catalogue Number: 20330320-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR