• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

OLYMPUS WINTER & IBE GMBH HF-CABLE, BIPOLAR; HF-GENERATORS Back to Search Results
Model Number WA00014A
Device Problem Unintended Electrical Shock (4018)
Patient Problem Electric Shock (2554)
Event Date 07/27/2021
Event Type  Injury  
Manufacturer Narrative
The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the consultant's outcome 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 transurethral resection in saline (turis) procedure, the hf-cable sheared off and delivered an electric shock to the consultant.The consultant's injuries were sore but she could finish the procedure with a similar device.No further information was provided.
 
Manufacturer Narrative
Additional information: d4 ¿ lot number, h4 ¿ device manufacturer date device evaluation: the suspect medical device was returned to the manufacturer for investigation/evaluation.The investigation confirmed that the hf cable is broken.The damage found is a known fault pattern.Age-related wear and tear in connection with repeated great bending and/or tensile loads most likely caused individual or all wires inside the cable to break.When the generator is activated, this can lead to voltage flashovers in the damaged area, which resulted in the formation of sparks and the complete severing of the wires/the connector.According to the article¿s lot number, the hf cable was manufactured in may 2017.It is therefore assumed that the hf cable was used longer than the 12 months the cable is designed for.Thus, this event/incident can most likely be attributed to age-related wear and tear in connection with improper handling by the customer and thus to use error.A material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the hf cable without showing any abnormalities.The case will be closed on olympus side with no further actions.However, the reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HF-CABLE, BIPOLAR
Type of Device
HF-GENERATORS
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg 22045
GM  22045
MDR Report Key12273239
MDR Text Key266034063
Report Number9610773-2021-00215
Device Sequence Number1
Product Code FAS
UDI-Device Identifier04042761076449
UDI-Public04042761076449
Combination Product (y/n)N
PMA/PMN Number
K120418
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 11/02/2021
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 NumberWA00014A
Device Catalogue NumberWA00014A
Device Lot Number175W
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/28/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/29/2021
Initial Date FDA Received08/04/2021
Supplement Dates Manufacturer Received10/28/2021
Supplement Dates FDA Received11/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
OLYMPUS ESG-400 HF-GENERATOR (B)(4).; OLYMPUS UNSPECIFIED RESECTOSCOPE.; OLYMPUS UNSPECIFIED SURGMASTER LOOP.
Patient Outcome(s) Other;
-
-