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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 Problems Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/24/2020
Event Type  Malfunction  
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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 Key10599180
Report Number9610773-2020-00226
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 BIOMEDICAL ENGINEER
Type of Report Initial,Followup
Report Date 10/27/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/29/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberWA51138A
Device Catalogue NumberWA51138A
Device LOT Number20403-0009
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/21/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/21/2020
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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