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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, ROLLER, 24-28 FR., 12° AND 30°
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OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, ROLLER, 24-28 FR., 12° AND 30° Back to Search Results
Model Number A22251C
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/12/2024
Event Type  Injury  
Event Description
It was reported, the roller ball portion of the hf-resection electrode, roller, 24-28 fr., 12° and 30° fell off into the patient during a therapeutic hysteroscopy with dilatation & curettage and endometrial ablation.A vaginal exam was performed to look for and retrieve the roller ball causing prolongation of the procedure for an unspecified duration.The patient's anesthesia was extended by a few minutes.The procedure was completed with a similar device.There were no reports of patient harm.
 
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Brand Name
HF-RESECTION ELECTRODE, ROLLER, 24-28 FR., 12° AND 30°
Type of Device
HF-RESECTION ELECTRODE
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg, hamburg 22045
GM  22045
MDR Report Key18596852
MDR Text Key333976010
Report Number2429304-2024-00093
Device Sequence Number1
Product Code GCP
UDI-Device Identifier14042761036815
UDI-Public14042761036815
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 01/17/2024,01/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberA22251C
Device Lot Number1000046910
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date01/17/2024
Event Location Hospital
Date Report to Manufacturer01/17/2024
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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