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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH WORKING ELEMENT, PASSIVE, FOR RESECTION IN SALINE; RIGID ENDOSCOPE WORKING GUIDE
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OLYMPUS WINTER & IBE GMBH WORKING ELEMENT, PASSIVE, FOR RESECTION IN SALINE; RIGID ENDOSCOPE WORKING GUIDE Back to Search Results
Model Number WA22367A
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Perforation (2001)
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported they heard a rumor there was a perforation while using the subject device during a gynecology procedure.
 
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Brand Name
WORKING ELEMENT, PASSIVE, FOR RESECTION IN SALINE
Common Device Name
RIGID ENDOSCOPE WORKING GUIDE
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg, de 22045
GM  22045
MDR Report Key19383688
Report Number2429304-2024-0000272
Device Sequence Number7072545
Product Code KNS
UDI-Device Identifier04042761066242
UDI-Public04042761066242
Combination Product (Y/N)N
Initial Reporter StatePR
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 05/23/2024
Report Date (Section F) 04/26/2024
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 NumberWA22367A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date04/26/2024
Event Location Hospital
Date Report to Manufacturer04/26/2024
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date05/23/2024
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
A42021A, OUTER SHEATH, 8.5 MM/26 FR., 2 STOPCOCKS.; A4211A, VIDEO ADAPTER "AR-T12EA", EYEPIECE CUP.
Outcome Attributed to Adverse Event Other;
Patient SexUnknown
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