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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH SUCTION/IRRIGATION TUBE, 5 X 360 MM, BUTTON, UNIPOLAR, FOR HIQ+ HANDLE SUCTIONIRRIGATION SYSTEM (HANDLE, VALVE TUBING, SUCTIONIRRIGATION TUBE)

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OLYMPUS WINTER & IBE GMBH SUCTION/IRRIGATION TUBE, 5 X 360 MM, BUTTON, UNIPOLAR, FOR HIQ+ HANDLE SUCTIONIRRIGATION SYSTEM (HANDLE, VALVE TUBING, SUCTIONIRRIGATION TUBE) Back to Search Results
Model Number WA51138A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Peritonitis (2252)
Event Date 04/29/2020
Event Type  Injury  
Manufacturer Narrative

The suspect medical device has not yet been returned to olympus for evaluation/investigation. Therefore, the exact cause of the patient¿s outcome and the reported phenomenon could not be determined and is being judged as unknown. However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.

 
Event Description

Olympus was informed that after a therapeutic total laparoscopic gastrectomy procedure the patient developed peritonitis. No further information was provided, but there were no reports of any device malfunctions.

 
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Brand NameSUCTION/IRRIGATION TUBE, 5 X 360 MM, BUTTON, UNIPOLAR, FOR HIQ+ HANDLE
Type of DeviceSUCTIONIRRIGATION SYSTEM (HANDLE, VALVE TUBING, SUCTIONIRRIGATION TUBE)
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg 22045
GM 22045
Manufacturer (Section G)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg
Manufacturer Contact
daniel wladow
kuehnstrasse 61
hamburg 22045
GM   22045
4940669662
MDR Report Key10037763
MDR Text Key192159862
Report Number9610773-2020-00116
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK923982
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/04/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/08/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberWA51138A
Device Catalogue NumberWA51138A
Device LOT Number175W
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/09/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/31/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/01/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 05/08/2020 Patient Sequence Number: 1
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