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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-CABLE, MONOPOLAR; HF CABLE, MONOPOLAR

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OLYMPUS WINTER & IBE GMBH HF-CABLE, MONOPOLAR; HF CABLE, MONOPOLAR Back to Search Results
Model Number A0393
Device Problems Arcing (2583); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/16/2022
Event Type  malfunction  
Event Description
Olympus technical support engineer was informed by the director of nursing at the user facility that the customer¿s high frequency (hf) monopolar cable reportedly ¿exploded¿ during procedure.The hf cable exploded and burnt towards the end where the hf cord connects to the hf generator unit.The user replaced the damaged hf cord with another of the same model and was able to complete the procedure.No death or injury to the patient or user was reported to olympus.
 
Manufacturer Narrative
The customer returned the referenced hf cable for evaluation.A visual inspection confirmed the end of the hf cable where the (male) plug is located is damaged and detached/separated from the cable.Exposed burnt/charred internal wires were identified.There were no signs of damage to the male and or female connectors.Minor deformation/kink was noted on the cable.The legal manufacturer (oste) performed a review of the device history records for the concerned device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The subject cable was manufactured in august 2011 and was sold in october 2018.The investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.The reported malfunction is a known issue.The age-related wear in connection with repeated extreme bending or tensile loads potentially led to the breakage of single or all wires in the cable which can contribute to a voltage spike at the damaged area when the generator is activated, resulting in a spark and complete disconnection of the plug.In general, the customer is required to check the function of all devices used prior to a procedure and a suitable replacement device must be provided during an application.As stated on the ifu (instructions for use manual) and as a preventative measure, the ifu states that the service life of the cable is limited to 12 months.After this time, the cable should no longer be used.Olympus will continue to monitor complaints for this device.
 
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Brand Name
HF-CABLE, MONOPOLAR
Type of Device
HF CABLE, MONOPOLAR
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg, hamburg 22045
GM  22045
Manufacturer Contact
daniel wladow
kuehnstrasse 61
hamburg 22045
GM   22045
4940669662
MDR Report Key14115741
MDR Text Key298773440
Report Number9610773-2022-00137
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier04042761001656
UDI-Public04042761001656
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K944201
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 04/14/2022
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 NumberA0393
Device Catalogue NumberA0393
Device Lot Number831088
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/04/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/16/2022
Initial Date FDA Received04/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/15/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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