MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION HD AUTOCLAVABLE CAMERA HEAD CH-S190-XZ-E

Model Number CH-S190-XZ-E

Device Problems Electrical /Electronic Property Problem (1198); Device Inoperable (1663)

Patient Problem Blood Loss (2597)

Event Date 02/17/2014

Event Type  malfunction  

Event Description

Olympus medical systems corp (omsc) was informed that during a right upper lobe of lung resection, the subject device was released continuously without operating the release button of the subject camera head, and the images froze at every release.The phenomenon occurred when the procedure was at the step that the position near pulmonary artery was treated, and because of the freeze of the image, the pulmonary artery was injured.The hemostasis was performed immediately, and the procedure was completed with the subject device.There was no aftermath or delay of the procedure.

Manufacturer Narrative

The subject device was returned to olympus for inspection.A tape was winded around the cable near the camera head of the subject device and a leak was observed at the point.After the tape was peeled off, a damage of the cable's surface was observed.Another damage of it was observed at the different position, and a leak was also observed there.During the function test, the failure of its remote switch 1 was observed.After the disassembly of the camera head, the corrosion of the switch circuit board was observed.There was no irregularity of the subject device with the device history record.According to the observation of the leakage of water and the corrosion of the switch circuit board, the water soaked into inside of the camera head, remote switch circuit board corroded and the phenomenon occurred.This report is being submitted as a medical device report in an abundance of caution.

• Brand Name: HD AUTOCLAVABLE CAMERA HEAD CH-S190-XZ-E
• Type of Device: CAMERA HEAD
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 2951 ishikawa-cho; hachioji-shi, tokyo 192- 8507; JA 192-8507
• Manufacturer Contact: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 26425177
• MDR Report Key: 3757454
• MDR Text Key: 4414792
• Report Number: 8010047-2014-00091
• Device Sequence Number: 1
• Product Code: KQM
• 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,Company Representative,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CH-S190-XZ-E
• Device Catalogue Number: CH-S190-XZ-E
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/25/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 02/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2012
• 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): Other
• Patient Age: 61 YR