MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION HD ENDOEYE LAPARO-THORACO VIDEOSCOPE

Model Number LTF-VH

Device Problems False Device Output (1226); Improper Device Output (2953)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2015

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to omsc for evaluation.Based upon evaluation of the subject device by omsc, the phenomenon duplicated.When the angulation control knob was rotated, the image disappeared.As the image unit alone duplicated the phenomenon, the event was attributed the unit.Further analysis revealed that the covering of the reset pulse signal line was partially damaged.While the covering was damaged and the angulation control knob was rotated, the reset pulse signal line touched the shield bundle that electrical level was equal to the gnd and then the event occurred.The subject device passed the leakage test.Inner parts of the insertion tube were arranged in good manner.There were no scratches or cuts on the outside surface.The manufacturing history was reviewed, with no irregularities related to this problem noted.Based on the finding, this phenomenon is most likely caused by ordinary wear and tear.

Event Description

Olympus medical system corp.(omsc) was informed that during an unspecified treatment, the image disappeared.The user facility reconnected the subject device to the video system center and restarted the system, but with no improvement and the image went fuzzy.The procedure was interrupted and replaced the subject device with a backup instrument.The procedure was completed and there was no patient harm reported.The subject device was one of the service equipment and it was the first time for the facility to use since delivered.Before using the subject device, it was sterilized in the facility.The region of the treatment was unknown.

• Brand Name: HD ENDOEYE LAPARO-THORACO VIDEOSCOPE
• Type of Device: LAPARO-THORACO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: susumu nishina ; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 26425177
• MDR Report Key: 4926204
• MDR Text Key: 22407525
• Report Number: 8010047-2015-00594
• Device Sequence Number: 1
• Product Code: HET
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Report Date: 06/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: LTF-VH
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/26/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1