• 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 WORKING ELEMENT, PASSIVE, FOR RESECTION IN SALINE WORKING ELEMENTS (MONOPOLAR, BIPOLAR, FOR KNIVES, FOR PROBES)

  • 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 WORKING ELEMENT, PASSIVE, FOR RESECTION IN SALINE WORKING ELEMENTS (MONOPOLAR, BIPOLAR, FOR KNIVES, FOR PROBES) Back to Search Results
Model Number WA22367A
Device Problems Output Problem (3005); Activation Problem (4042)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 12/15/2021
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 patient'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 hysteroscopic procedure it was not possible to effectively cut tissue and stop the bleeding. Error e006 was issued on the hf generator due to poor contact between electrode and hysteroscope base. The surgeon then used a forceps to bend and firmly connect the electrode to the base of the hysteroscope. The intended procedure was then completed. However, the failure led to a significant prolongation of the surgery time and significantly increased bleeding.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameWORKING ELEMENT, PASSIVE, FOR RESECTION IN SALINE
Type of DeviceWORKING ELEMENTS (MONOPOLAR, BIPOLAR, FOR KNIVES, FOR PROBES)
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg 22045
GM 22045
Manufacturer (Section G)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg
Manufacturer Contact
daniel wladow
kuehnstrasse 61
hamburg 22045
GM   22045
4940669662
MDR Report Key13222539
MDR Text Key283589241
Report Number9610773-2022-00048
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K030194
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberWA22367A
Device Catalogue NumberWA22367A
Device Lot Number18ZW
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 01/11/2022 Patient Sequence Number: 1
Treatment
OLYMPUS ESG-400 HF-GENERATOR (WB91051C); OLYMPUS HF-CABLE (WA00014A)
-
-