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

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE 3-LUMEN SPHINCTEROTOME V SINGLE USE 2-LUMEN SPHINCTEROTOME

  • 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 MEDICAL SYSTEMS CORP. SINGLE USE 3-LUMEN SPHINCTEROTOME V SINGLE USE 2-LUMEN SPHINCTEROTOME Back to Search Results
Model Number KD-V411M-0720
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/07/2022
Event Type  malfunction  
Manufacturer Narrative
The subject device was returned to olympus for evaluation. The device inspection and testing confirmed the knife wire was broken. The broken part was black and melted. The outer diameter was measured and no abnormalities were observed. No issues were identified with the length of the knife wire and wire coating. No defects were found with the device. No other issues that could have led to the breakage of the knife wire were identified. The investigation is ongoing; therefore, a definitive root cause of the reported event cannot be determined at this time. If additional information becomes available, this report will be supplemented accordingly.
 
Event Description
The customer reported that during an endoscopic sphincterotomy, the knife wire broke when the device was energized. There were no fragments observed in the patient's body. Another similar device was used to successfully complete the intended procedure. There was no patient or user injury reported due to the event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSINGLE USE 3-LUMEN SPHINCTEROTOME V
Type of DeviceSINGLE USE 2-LUMEN SPHINCTEROTOME
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA 192-8507
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key14016893
MDR Text Key298128758
Report Number8010047-2022-05717
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K950166
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 06/29/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberKD-V411M-0720
Device Lot Number18K
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/17/2022
Was the Report Sent to FDA? No
Date Manufacturer Received06/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/23/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-