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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HALOGEN LIGHT SOURCE

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OLYMPUS MEDICAL SYSTEMS CORP. HALOGEN LIGHT SOURCE Back to Search Results
Model Number CLK-4
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Laceration(s) (1946)
Event Date 02/28/2019
Event Type  Injury  
Manufacturer Narrative

The device was not returned to olympus for evaluation. Olympus followed up with the user facility to obtain additional information, and was informed by the clinical manager that the cable attached to the device was wrapped around the examination table and became caught; causing the device to fall onto the patient¿s head and then onto the floor. The intended cystoscopy procedure was completed. The clinical manager confirmed that the device did not malfunction and did not caused the patient's injury but declined to provide further information regarding the patient.

 
Event Description

Olympus was informed that at the end of a diagnostic procedure, the device fell off the shelf, onto the patient¿s arm and then onto the floor; scratching the patient and damaging the housing of the device. The patient was taken to urgent care immediately and the patient is reportedly doing fine.

 
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Brand NameHALOGEN LIGHT SOURCE
Type of DeviceHALOGEN LIGHT SOURCE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA 192-8507
Manufacturer Contact
connie tubera
2400 ringwood avenue
san jose, CA 95131
4089355124
MDR Report Key8423322
MDR Text Key138902512
Report Number2951238-2019-00543
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK993041
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 03/14/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/14/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL NumberCLK-4
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/01/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 03/14/2019 Patient Sequence Number: 1
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