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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH INNER SHEATH, FOR 26 FR. OUTER SHEATH; REUSABLE ENDOSCOPE SHEATH
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OLYMPUS WINTER & IBE GMBH INNER SHEATH, FOR 26 FR. OUTER SHEATH; REUSABLE ENDOSCOPE SHEATH Back to Search Results
Model Number A22040A
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/26/2024
Event Type  Injury  
Event Description
It was reported that the ceramic beak of the reusable endoscope sheath fell inside the patient during a transurethral resection of prostate and was retrieved using a disposable flexible basket.The procedure was extended by 20 minutes and was completed with a similar device.The device was reportedly inspected prior to use.The patient was stable and recovering.There were no reports of patient harm.
 
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Brand Name
INNER SHEATH, FOR 26 FR. OUTER SHEATH
Type of Device
REUSABLE ENDOSCOPE SHEATH
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg, hamburg 22045
GM  22045
MDR Report Key18719310
MDR Text Key335523203
Report Number2429304-2024-00111
Device Sequence Number1
Product Code HIH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/01/2024,02/16/2024
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? Yes
Device Operator Health Professional
Device Model NumberA22040A
Device Lot Number23706
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date02/01/2024
Event Location Hospital
Date Report to Manufacturer02/01/2024
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/16/2024
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexMale
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