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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH VERSAPOINT II BIPOLAR ELECTRODE RESECTOSCOPIC - 4.0 MM ANGLED LOOP, RESECTING; HF-ELECTRODES

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OLYMPUS WINTER & IBE GMBH VERSAPOINT II BIPOLAR ELECTRODE RESECTOSCOPIC - 4.0 MM ANGLED LOOP, RESECTING; HF-ELECTRODES Back to Search Results
Model Number WA47787A
Device Problems Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/14/2021
Event Type  malfunction  
Event Description
Olympus was informed that during a therapeutic hysteroscopic myomectomy procedure the loop wire at the distal end of two hf electrodes of the same lot broke off and fell into the patient.However, no fragments remained inside the patient since they were reportedly retrieved.As a result of the failure, the procedure time was prolonged by approx.20 minutes but the intended procedure was completed and there was no report about an adverse event or patient injury.
 
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.
 
Manufacturer Narrative
The suspect medical devices were returned to the manufacturer for evaluation/investigation.The evaluation/investigation confirmed that the loop wires at the distal end of the two hf electrodes are broken off due to brittle failure.Thus, the reported event/incident was attributed to component failure.This is a known error pattern, which has already been examined in the past.However, it was assessed that a material change was not required based on the very low number of occurrences of this failure mode.A manufacturing and quality control review was performed for the affected lot number of the hf resection electrodes without showing any abnormalities.The case will be closed on olympus side with no further actions.However, the reported phenomenon will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.
 
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Brand Name
VERSAPOINT II BIPOLAR ELECTRODE RESECTOSCOPIC - 4.0 MM ANGLED LOOP, RESECTING
Type of Device
HF-ELECTRODES
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg 22045
GM  22045
Manufacturer (Section G)
GYRUS MEDICAL LTD.
fortran road
st. mellons
cardiff
Manufacturer Contact
daniel wladow
kuehnstrasse 61
hamburg 22045
GM   22045
4940669662
MDR Report Key12874027
MDR Text Key285620352
Report Number9610773-2021-00340
Device Sequence Number1
Product Code HIN
UDI-Device Identifier14042761086261
UDI-Public14042761086261
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K111751
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative,Distributor
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 02/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberWA47787A
Device Catalogue NumberWA47787A
Device Lot NumberU2001167
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/08/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/19/2021
Initial Date FDA Received11/25/2021
Supplement Dates Manufacturer Received02/08/2022
Supplement Dates FDA Received02/10/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/27/2020
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 SexFemale
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