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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OUTER SHEATH, 26 FR., 2 STOPCOCKS, ROTATABLE
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OLYMPUS WINTER & IBE GMBH OUTER SHEATH, 26 FR., 2 STOPCOCKS, ROTATABLE Back to Search Results
Model Number A22026A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Tissue Damage (2104)
Event Type  Injury  
Event Description
The manufacturer was informed by the doctor at the user facility that the connection where the hf resection inner and outer sheath meet (a22040a and a22026a) has the potential to tear the urethra of the patients.The doctor reported that the event has happened before but the doctor did not provide additional information regarding the event or patient.Additionally, the doctor reported that they believe it is one resectoscope set of sheaths that caused the reported event.The user facility utilizes 3rd party repairs for their equipment.This is 2 of 2 devices.
 
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Brand Name
OUTER SHEATH, 26 FR., 2 STOPCOCKS, ROTATABLE
Type of Device
OUTER SHEATH
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg 22045
GM  22045
MDR Report Key8804572
MDR Text Key151501091
Report Number2951238-2019-01017
Device Sequence Number1
Product Code GCP
UDI-Device Identifier04042761029346
UDI-Public04042761029346
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/21/2019,07/18/2019
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? Yes
Device Operator Health Professional
Device Model NumberA22026A
Device Catalogue NumberA22026A
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/21/2019
Event Location Hospital
Date Report to Manufacturer06/21/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
INNER SHEATH:OLYMPUS A22040A LOT UNKNOWN
Patient Outcome(s) Other;
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