MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA ELITE VIDEO SYSTEM CENTER; VIDEO PROCESSOR

Model Number OTV-S190

Device Problems No Display/Image (1183); Improper or Incorrect Procedure or Method (2017)

Patient Problem Bowel Perforation (2668)

Event Date 09/04/2015

Event Type  Injury  

Manufacturer Narrative

The referenced otv-s190 is not returned to olympus medical systems corp.(omsc) for evaluation, therefore omsc cannot evaluate the otv-s190.The exact cause of the reported event could not be conclusively determined at this time.If significant additional information is received, this report will be supplemented.This report is being submitted as a medical device report in an abundance of caution.

Event Description

Olympus was informed that during the laparoscopic total hysterectomy, when the physician completed the resection of the patient's vaginal fornix the endoscopic image was disappeared.At that time the physician perforated the patient's small intestine accidentally.The physician cycled the power of the otv-s190, but the endoscopic image was not displayed on the monitor.Therefore the physician completed the procedure with use of the similar but other device, and then treated the damage of the patient's small intestine.

• Brand Name: VISERA ELITE VIDEO SYSTEM CENTER
• Type of Device: VIDEO PROCESSOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer (Section G): OLYMPUS MEDICAL SYSTEMS CORP.; 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: 5113003
• MDR Text Key: 27084916
• Report Number: 8010047-2015-00931
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K954451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Report Date: 09/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: OTV-S190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/30/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 79 YR
• Patient Weight: 67