Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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-RESECTION ELECTRODE, LOOP; ENDOSCOPES, AC-POWERED AND ACCESSORIES
  • 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-RESECTION ELECTRODE, LOOP; ENDOSCOPES, AC-POWERED AND ACCESSORIES Back to Search Results
Model Number A22201C
Health Effect - Clinical Code Foreign Body In Patient (2687)
Date of Event 09/15/2022
Type of Reportable Event Serious Injury
Event or Problem Description
Olympus received a voluntary mw reporting an unspecified procedure during which a resection electrode loop 24f broke inside the patient.Olympus is unable to request additional details regarding the patient or reported event, the reporter requested identity and contact information remain confidential.The device will not be returned for evaluation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HF-RESECTION ELECTRODE, LOOP
Common Device Name
ENDOSCOPES, AC-POWERED AND ACCESSORIES
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg, hamburg 22014 5
GM  220145
MDR Report Key15739443
Report Number2429304-2022-00107
Device Sequence Number20424017
Product Code GCP
UDI-Device Identifier14042761036648
UDI-Public14042761036648
Combination Product (Y/N)N
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Physician Assistant
Type of Report Initial
Report Date (Section B) 11/04/2022
Report Date (Section F) 10/07/2022
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
Operator of Device Health Professional
Device Expiration Date09/27/2023
Device Model NumberA22201C
Device Catalogue NumberA22201C
Device Lot Number1000033994
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date10/07/2022
Date Report to Manufacturer10/07/2022
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date11/04/2022
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient SexUnknown
-
-