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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, 12, STERILE, SINGLE USE, HF-RESECTION ELECTRODES

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OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, 12, STERILE, SINGLE USE, HF-RESECTION ELECTRODES Back to Search Results
Model Number A22201D
Device Problems Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/19/2020
Event Type  malfunction  
Manufacturer Narrative
The suspect medical device has not yet been returned to olympus for evaluation/investigation. Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined and is being judged as unknown. However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.
 
Event Description
Olympus was informed that during a therapeutic transcervical resection of fibroids (tcrf) procedure, the loop wire at the distal end of the hf-resection electrode detached. It is unknown whether the detached parts remained inside the patient¿s body since they could not be found within an x-ray examination of the patient or when searching the facility. The intended procedure was successfully completed with the same set of equipment and there was no report about an adverse event or patient injury.
 
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Brand NameHF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, 12, STERILE, SINGLE USE,
Type of DeviceHF-RESECTION ELECTRODES
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg 22045
GM 22045
Manufacturer (Section G)
OLYMPUS MEDICAL PRODUCTS CZECH, SPOL. S R.O.
telickova 457/29
prerov
Manufacturer Contact
daniel wladow
kuehnstrasse 61
hamburg 22045
GM   22045
4940669662
MDR Report Key10895237
MDR Text Key226955377
Report Number9610773-2020-00277
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K903323
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/31/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberA22201D
Device Catalogue NumberA22201D
Device Lot Number16014P03L001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/25/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/14/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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