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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 24 FR.; HYSTEROSCOPE (AND ACCESSORIES)

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OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 24 FR.; HYSTEROSCOPE (AND ACCESSORIES) Back to Search Results
Model Number A22041A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Urethral Stenosis/Stricture (4501)
Event Type  Injury  
Manufacturer Narrative
The device was returned for evaluation and the customers allegation could not be confirmed.No external abnormalities were found.The sheath, electrode, and reflux sheath were all assembled, and no abnormalities were found.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
 
Event Description
The patients experienced consecutive urethral strictures after transurethral resection in saline (turis) procedures in which the working element (wa22366a) and 24fr resection sheath (a22041a) were used in combination.The procedure was completed using the same device and no additional medical treatment or surgical intervention was required.The physician opinion is that either the handle or the sheath was the cause.Related patient identifiers: (b)(6) working element, active, for resection in saline (wa22366a / 147w0080).(b)(6) working element, active, for resection in saline (wa22366a / 147w0080).(b)(6) resection sheath, 24 fr.(a22041a / 147w0083).(b)(6) resection sheath, 24 fr.(a22041a / 147w0083).This medwatch is for patient identifier (b)(6).
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the subject device meets specification and a specific root cause of the reported event could not be determined.Olympus will continue to monitor field performance for this device.
 
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Brand Name
RESECTION SHEATH, 24 FR.
Type of Device
HYSTEROSCOPE (AND ACCESSORIES)
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg, hamburg 22045
GM  22045
Manufacturer (Section G)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key18219365
MDR Text Key329196601
Report Number9610773-2023-03397
Device Sequence Number1
Product Code HIH
UDI-Device Identifier04042761020961
UDI-Public04042761020961
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K931994
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/26/2024
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
Device Operator Health Professional
Device Model NumberA22041A
Device Lot Number147W-0083
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/10/2023
Was the Report Sent to FDA? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/28/2023
Supplement Dates Manufacturer Received02/22/2024
Supplement Dates FDA Received02/26/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/04/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
WORKING ELEMENT (B)(6) / 147W0080
Patient Outcome(s) Other;
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