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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12°

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OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12° Back to Search Results
Model Number WA22302D
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 11/27/2023
Event Type  Injury  
Event Description
It was reported that during a therapeutic hysteroscopic adhesiolysis/endometrial resection for a scarred uterus under general anesthesia, the hf-resection electrode, loop, 24 fr., 0.2 wire, medium, 12° loop was broken and embedded in the tissue (uterine floor).The loop was then clamped with vascular forceps and removed from the patient.Follow up indicated that the loop broke due to touching metal during the surgery.It was initially reported that the event prolonged the patients surgical time, but follow up indicated there was no delay.The procedure was completed with a similar device.
 
Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
 
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Brand Name
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12°
Type of Device
HF-RESECTION ELECTRODE
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg, hamburg 22045
GM  22045
Manufacturer (Section G)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg 22045
GM   22045
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key18355027
MDR Text Key330876725
Report Number9610773-2023-03685
Device Sequence Number1
Product Code FAS
UDI-Device Identifier14042761051665
UDI-Public14042761051665
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K120418
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 12/19/2023
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 NumberWA22302D
Device Lot Number1000102086
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/01/2023
Initial Date FDA Received12/19/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/22/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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