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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-CABLE, BIPOLAR; ELECTRICAL-ONLY MEDICAL DEVICE CONNECTION CABLE, REUSABLE
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OLYMPUS WINTER & IBE GMBH HF-CABLE, BIPOLAR; ELECTRICAL-ONLY MEDICAL DEVICE CONNECTION CABLE, REUSABLE Back to Search Results
Model Number WA00014A
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/25/2024
Event Type  malfunction  
Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported, that the subject device made a popping sound and sparked, and the cable was burned and broken.The issue occurred during a therapeutic transurethral resection of the prostate in saline (turis) procedure.The procedure was completed using a similar device.There were no reports of patient harm.
 
Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.B5 was corrected.Additional information added to fields d8, d9, h3, and h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 6 years since the subject device was manufactured.The device was returned to olympus for inspection, and the customer's complaint was confirmed.Based on the results of the investigation, it is likely the following led to the malfunction: the age-related wear and tear in connection with repeated strong bending or tensile loads most likely led to the breakage of individual or all strands in the cable.The event can be detected/prevented by following the instructions for use: firstly, the lifespan of the cable is limited to 12 months.After this time, the cable should not be used any more.Furthermore, the cable must be checked for damage before each use and after reprocessing.By gently pulling on the plug (max.20n), it can be determined whether the copper strand of the cable is damaged.If the cable does not give way but remains rigid, it is highly likely that the cable is ok at this point.In order not to further shorten the lifespan of the cable, the cable should not be wound up with a loop diameter of less than 10 cm and when pulling out the cable, the plug should be pulled and not the cable.Olympus will continue to monitor field performance for this device.
 
Event Description
It was reported, that the subject device made a popping sound and sparked, and the cable was burned and broken.The issue occurred during a therapeutic transurethral resection of the prostate in saline (turis) procedure.The procedure was completed using a similar device after a five minute delay.There were no reports of patient harm.
 
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Brand Name
HF-CABLE, BIPOLAR
Type of Device
ELECTRICAL-ONLY MEDICAL DEVICE CONNECTION CABLE, REUSABLE
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg, hamburg 22045
GM  22045
Manufacturer (Section G)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg, hamburg 22045
GM   22045
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key19053373
MDR Text Key339505988
Report Number9610773-2024-00966
Device Sequence Number1
Product Code FAS
UDI-Device Identifier04042761076449
UDI-Public04042761076449
Combination Product (y/n)N
Reporter Country CodeHK
PMA/PMN Number
K120418
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/05/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberWA00014A
Device Lot Number184W-1910
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/27/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
ESG-400 - ELECTROSUGRICAL HF GENERATOR
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