OLYMPUS CV 160 LIGHT SOURCE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-12-06 for OLYMPUS CV 160 LIGHT SOURCE * manufactured by Olympus America Inc.

Event Text Entries

[138751] The light filters were not in filter holder on a new olympus cv-160 light source causing overheating of 4 gi scopes, destruction of the fiber bundles and possible pt burns with fourth scope. The filters, separator ring and expansion ring were subsequently found inside on the bottom of the light source. The fourth scope cf160 qal had burning of the rubber fiber bundle interface at the distal end of the scope and vaporized water when placed in a cup of water. Set up two new olympus video systems and informed they were ready for use. Colonoscope cf 1t 140l used, the light became dim during a colonscopy procedure. Gastroscope gif 1t 140l used, light bright and then dim during gastroscopy. Colonoscope cf 1t 140l connected to light source, light dim, endoscope not used. The new video system was removed from the room. The light guide glass was dark in all three endoscopes. Informed the co the endoscopes may have fluid incasion and it was okay to use the video system. The same clv and cv unit was used with colonoscope cf 160 qal procedure was being done when smoke was seen from the distal tip of the colonoscope, smoke was also smelled. The colonoscope was removed without apparent adversity to the pt. The video system was removed from the procedure room. The second new video system used: clv 160 light source, colonoscope cf 160 qal, procedure was being done when physician and nurse saw smoke from distal tip of colonoscope. The colonoscope was removed without apparent adversity to the pt. The second video system was removed from the procedure room.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 308527
• MDR Report Key: 308527
• Date Received: 2000-12-06
• Date of Report: 2000-12-05
• Date of Event: 2000-11-15
• Date Facility Aware: 2000-11-15
• Report Date: 2000-12-05
• Date Reported to FDA: 2000-12-05
• Date Reported to Mfgr: 2000-12-05
• Date Added to Maude: 2000-12-15
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: OLYMPUS
• Generic Name: COLONOSCOPE AND LIGHT SOURCE
• Product Code: KOG
• Date Received: 2000-12-06
• Model Number: CV 160 LIGHT SOURCE
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 298503
• Manufacturer: OLYMPUS AMERICA INC
• Manufacturer Address: 2400 RINGWOOD AVE SAN JOSE CA 95131 US
• Baseline Brand Name: OLYMPUS
• Baseline Generic Name: LIGHT SOURCE
• Baseline Model No: CLV-160
• Baseline Catalog No: NA
• Baseline ID: NA
• Baseline Device Family: NA
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K954451
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Device Sequence Number: 2

• Brand Name: OLYMPUS
• Generic Name: PROCESSOR
• Product Code: EQH
• Date Received: 2000-12-06
• Model Number: CV160
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 298505
• Manufacturer: OLYMPUS AMERICA INC
• Manufacturer Address: 2400 RINGWOOD AVE SAN JOSE CA 95131 US

Device Sequence Number: 3

• Brand Name: OLYMPUS
• Generic Name: COLONOSCOPE
• Product Code: FTJ
• Date Received: 2000-12-06
• Model Number: CF1T140L
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 3
• Device Event Key: 298508
• Manufacturer: OLYMPUS AMERICA INC
• Manufacturer Address: 2400 RINGWOOD AVE SAN JOSE CA 95131 US

Device Sequence Number: 4

• Brand Name: OLYMPUS
• Generic Name: GASTROSCOPE
• Product Code: FDF
• Date Received: 2000-12-06
• Model Number: GIF1T140L
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 4
• Device Event Key: 298509
• Manufacturer: OLYMPUS AMERICA INC
• Manufacturer Address: 2400 RINGWOOD AVE SAN JOSE CA 95131 US

Device Sequence Number: 5

• Brand Name: OLYMPUS
• Generic Name: COLONOSCOPE
• Product Code: FDF
• Date Received: 2000-12-06
• Model Number: CF1T140L
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 5
• Device Event Key: 298512
• Manufacturer: OLYMPUS AMERICA INC
• Manufacturer Address: 2400 RINGWOOD AVE SAN JOSE CA 95131 US

Device Sequence Number: 6

• Brand Name: OLYMPUS
• Generic Name: COLONOSCOPE
• Product Code: FDF
• Date Received: 2000-12-06
• Model Number: CF160QAL
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 6
• Device Event Key: 298514
• Manufacturer: OLYMPUS AMERICA INC
• Manufacturer Address: 2400 RINGWOOD AVE SAN JOSE CA 95131 US

Device Sequence Number: 7

• Brand Name: OLYMPUS
• Generic Name: LIGHT SOURCE
• Product Code: EQH
• Date Received: 2000-12-06
• Model Number: CLV160
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 7
• Device Event Key: 298519
• Manufacturer: OLYMPUS AMERICA INC
• Manufacturer Address: 2400 RINGWOOD AVE SAN JOSE CA 95131 US

Device Sequence Number: 8

• Brand Name: OLYMPUS
• Generic Name: PROCESSOR
• Product Code: EQH
• Date Received: 2000-12-06
• Model Number: CV160
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 8
• Device Event Key: 298523
• Manufacturer: OLYMPUS AMERICA INC
• Manufacturer Address: 2400 RINGWOOD AVE SAN JOSE CA 95131 US

Device Sequence Number: 9

• Brand Name: OLYMPUS
• Generic Name: COLONOSCOPE
• Product Code: FTJ
• Date Received: 2000-12-06
• Model Number: CF160QAL
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 9
• Device Event Key: 298526
• Manufacturer: OLYMPUS AMERICA INC
• Manufacturer Address: 2400 RINGWOOD AVE SAN JOSE CA 95131 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2000-12-06