• 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 PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED)

  • 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 PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED) Back to Search Results
Model Number KD-VC611Q-07301S
Device Problems Break (1069); Melted (1385); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/02/2022
Event Type  malfunction  
Manufacturer Narrative
The device is expected to be returned to olympus for evaluation; however, the device has not been received. The investigation is ongoing; therefore, a 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 pharmacist at the user facility reported that the cutting wire of the sphincterotome broke during a procedure. The procedure was completed using a similar device. There was no patient harm or user injury reported due to the event. Three attempts were performed to obtain additional information, but no response was received from the customer.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED)
Type of DeviceSINGLE USE PRELOADED 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 Key13742788
MDR Text Key296870937
Report Number8010047-2022-04335
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K141991
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 05/23/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/12/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberKD-VC611Q-07301S
Device Lot Number1804V/14V
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/26/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/07/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-