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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE LIGATING DEVICE
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OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE LIGATING DEVICE Back to Search Results
Model Number HX-400U-30
Device Problems Separation Failure (2547); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/14/2021
Event Type  Injury  
Event Description
It is reported by the customer, a single use ligating device was used during a colonoscopy procedure.Once the loop was deployed, the user was unable to detach it from the catheter and became stuck in the patient.A second scope was inserted, and the user inserted endoscopic scissors into the working channel of the second scope.The scissors were used to cut the loop(suture) and the initial device was removed.The procedure was completed without any further complications using the second scope.The patient is currently well.There were no further consequences to the patient because of this occurrence.
 
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Brand Name
SINGLE USE LIGATING DEVICE
Type of Device
SINGLE USE LIGATING DEVICE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
MDR Report Key12312714
MDR Text Key266362839
Report Number2951238-2021-00377
Device Sequence Number1
Product Code FHN
UDI-Device Identifier04953170368615
UDI-Public04953170368615
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Nurse
Type of Report Initial
Report Date 07/14/2021,08/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberHX-400U-30
Device Lot Number08V
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date07/14/2021
Event Location Hospital
Date Report to Manufacturer07/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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