MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY ENDOMAT LC PUMP FOR SUCTION ONLY; SUCTION PUMP

Model Number	20330320-1
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the hospital, they wil not return the unit since it was user error.
Event or Problem Description
Allegedly, during a turp procedure, the endomat pump tubing was mistakenly hooked up backwards.The hospital did not believe the waste fluid reached the patient's bladder but, as a precaution, iv antibiotics were administered to the patient.Hospital reported the patient is doing fine.
Event or Problem Description
Allegedly, during a turp procedure, the endomat pump tubing was mistakenly hooked up backwards.The doctor noticed the fluid was coming inflow instead of outflow.The hospital did not believe the waste fluid reached the patient's bladder but, as a precaution, iv antibiotics were administered to the patient.Hospital reported the patient is doing fine.

• Brand Name: ENDOMAT LC PUMP FOR SUCTION ONLY
• Common Device Name: SUCTION PUMP
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY; mittlestrasse 8,; 78503; tuttlingen
• MDR Report Key: 6942963
• Report Number: 9610617-2017-00086
• Device Sequence Number: 745388
• Product Code: OCX
• UDI-Device Identifier: 04048551066423
• UDI-Public: 4048551066423
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K031457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2017

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: Physician
• Device Model Number: 20330320-1
• Device Catalogue Number: 20330320-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/11/2017
• Supplement Date Received by Manufacturer: 09/11/2017
• Initial Report FDA Received Date: 10/11/2017
• Supplement Report FDA Received Date: 10/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1