• 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 INNER SHEATH, FOR 26 FR. OUTER SHEATH; RESECTOSCOPE SHEATH

  • 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 INNER SHEATH, FOR 26 FR. OUTER SHEATH; RESECTOSCOPE SHEATH Back to Search Results
Model Number A22040A
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/14/2023
Event Type  malfunction  
Manufacturer Narrative
The device was returned and evaluated, and the customer¿s allegation was confirmed.In addition to the ceramic tip being damaged, the tube had dents.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
 
Event Description
The customer reported to olympus that the inner sheath, for 26 fr.Outer sheath outer shell was damaged.The event occurred during preparation for use in a diagnostic procedure.The procedure was completed with a similar device.There was no patient harm associated with the event.The device was evaluated, and it was found the ceramic tip was damaged.This mdr (medical device report) is being submitted to capture the reportable malfunction found during the device evaluation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INNER SHEATH, FOR 26 FR. OUTER SHEATH
Type of Device
RESECTOSCOPE SHEATH
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg, hamburg 22045
GM  22045
Manufacturer (Section G)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg 22045
GM   22045
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key18408587
MDR Text Key331497188
Report Number9610773-2023-03785
Device Sequence Number1
Product Code HIH
UDI-Device Identifier04042761029339
UDI-Public04042761029339
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K931995
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 12/28/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberA22040A
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2023
Was the Report Sent to FDA? No
Date Manufacturer Received12/21/2023
Was Device Evaluated by Manufacturer? Yes
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
CV-190
-
-