MAUDE Adverse Event Report: OLYMPUS MED SYS CORP SCOPE CABLE EXERA II

Model Number MAJ-1430

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Electric Shock (2554)

Event Date 02/19/2014

Event Type  malfunction  

Event Description

Olympus was informed that the nurse received a mild electrical shock when attaching the video cable to the endoscope.No other info was provided.Olympus followed up with the user facility to obtain add'l info and was informed that the event occurred during the set up process of a colonoscopy.The gi tech felt the electrical shock from the hand to the elbow.There was no pt involvement.No medical treatment was required.

Manufacturer Narrative

The device was returned to olympus for eval.The eval was unable to duplicate the reported phenomenon.The video scope cable was connected to the olympus test equipment and no shock was felt while holding it during the investigation.In addition, both connectors were disassembled but found no corrosion and all wirings and parts were grounded correctly.Evidence of fluid invasion was noted beneath the serial number plate and factory number.Scratch marks on the round connector and black stains on the contact pins were also noted.The device passed the continuity test.The device was returned unrepaired per customer's request.Per instruction manual "if the device is used while still wet, there is the risk of an electric shock.".

• Brand Name: SCOPE CABLE EXERA II
• Type of Device: SCOPE CABLE
• Manufacturer (Section D): OLYMPUS MED SYS CORP; 2951 ishikawa-cho; hachioji-shi; tokyo 192- 8507; JA 192-8507
• Manufacturer (Section G): OLYMPUS MED SYS CORP; 2951 ishikawa-cho; hachioji-shi; tokyo 192- 8507; JA 192-8507
• Manufacturer Contact: noemi schambach ; 2400 ringwood ave.; san jose, CA 95131 ; 4089355002
• MDR Report Key: 3830019
• MDR Text Key: 4398422
• Report Number: 2951238-2014-00107
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-1430
• Device Catalogue Number: MAJ-1430
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1