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 06/15/2015

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to omsc for investigation.The evaluation.Based upon the evaluation of the subject device by omsc, the phenomenon duplicated.The subject device passed the leakage test.The service record was also reviewed and it was revealed that the subject device was assembled with the insertion unit fabricated in (b)(6) 2014.The manufacturing history was reviewed w/no irregularities related to this problem noted.The exact cause could not be conclusively determined at this time.If any add'l info becomes available at a later time, this report will be supplemented.

Event Description

Olympus medical systems, corp.(omsc), was informed that after about one hour from the start of laparoscopic total gastrectomy, the image of the subject device disappeared.The subject device was replaced with a backup instrument that was same model w/the subject device.The procedure was completed and there was no patient harm.

Manufacturer Narrative

This supplemental report is being submitted as additional information became available.Olympus disassembled the subject device and conducted further evaluation.There were no irregularities in the soldering of the video connector, and in the forming of inner cables.There were no buckling or cut in the cables.The outer appearance and the external diameter of the image unit were checked, with no irregularities found.There were no irregularities in the value of resistance and bias voltage.Adhesion area and its hardening condition, the cable unit and soldering of ccd were also checked, with no irregularities noted.Based upon the evaluation, as no irregularities were noted, damage in the ccd or the signal shaping circuit due to electrical stress such as static electricity could not be ruled out as a contributory factor of the event.

• Brand Name: HD ENDOEYE LAPARO-THORACO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 2951 ishikawa-cho; hachioji-shi 192-8 507; JA 192-8507
• Manufacturer Contact: 2951 ishikawa-cho; hachioji-shi 192-8-507 ; 26425177
• MDR Report Key: 4987751
• MDR Text Key: 23682751
• Report Number: 8010047-2015-00637
• Device Sequence Number: 1
• Product Code: HET
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K080948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Report Date: 07/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: LTF-VH
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/14/2015
• Date Manufacturer Received: 09/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1