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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. VISERA XENON LIGHT SOURCE Back to Search Results
Model Number CLV-S40
Device Problem Temperature Problem (3022)
Patient Problems Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)
Event Date 06/21/2019
Event Type  Injury  
Manufacturer Narrative
The referenced clv-s40 was not returned yet to olympus medical systems corp. (omsc) for evaluation at this time, therefore omsc could not evaluate the clv-s40. There were no further details provided. The exact cause of the reported event could not be conclusively determined at this time. If additional information, this report will be supplemented.
 
Event Description
Olympus was informed that during the laparoscopic uterine myomectomy and uterine adnexectomy, the clv-s40 was used in combination with non-olympus (karl storz) devices (a video processor, a camera head and a rigid endoscope) and unspecified olympus surgical technologies europe (oste) light guide. After the surgery, the physician located the rigid endoscope on the patient¿s right thigh during the skin suture. Subsequently the patient suffered one second-degree burn and three first-degree burns on her thigh by the tip of the rigid endoscope. Regarding the burns, the patient was treated at the department of dermatology and then recovered.
 
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Brand NameVISERA XENON LIGHT SOURCE
Type of DeviceXENON LIGHT SOURCE
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 Key8797974
MDR Text Key151285706
Report Number8010047-2019-02567
Device Sequence Number1
Product Code GCT
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 09/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCLV-S40
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 Received07/16/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/25/2004
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: 07/17/2019 Patient Sequence Number: 1
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