MAUDE Adverse Event Report: INTEGRA BURLINGTON, MA, INC. OJEMAN CORTICAL STIMULATOR ; NONE

Catalog Number OCS2

Device Problems Device Alarm System (1012); Low impedance (2285); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 07/02/2014

Event Type  malfunction  

Event Description

The product was tested by the customer and the results were the following: at the lower impedances, the error was not seen.However, as the impedance increases to a more realistic level, an error was noted.The unit stopped indicating the current and any stimulation when the out voltage reached 40v.It continued to deliver the current with no indication that it was doing so.The meter was set to overload, the green led current indicator stopped flashing, and the audible click stopped.But the unit still delivered the current through the output probe which could be increased and seen to increase on the oscilloscope via the range knob on the unit.There was no pt involved.There was no injury.

Manufacturer Narrative

To date, the device involved in the reported incident has not been received for eval.An investigation has been initiated based upon the reported info.

Manufacturer Narrative

Additional information was received with the following: the correct serial number of the involved device is serial number (b)(4) (previously provided by the reporter as (b)(4)) integra has completed their internal investigation on 3/23/2016.The investigation included: methods: evaluation of actual device, review of device history records, review of complaint history.Results: the technician observed that neither the power transformer nor the capacitor (c-7) was functioning.Malfunction of either of these two components would prevent the ocs2 from functioning properly.The device passed all qc and final inspection tests before the product was returned to the customer.There was no trend on this complaint for this issue for past complaints.The customer's complaint was not duplicated, however, issues with electrical components (transformer and capacitor) were noted.Both components were not functioning entirely.Without these two components functioning a root cause cannot be assessed.

• Brand Name: OJEMAN CORTICAL STIMULATOR
• Type of Device: NONE
• Manufacturer (Section D): INTEGRA BURLINGTON, MA, INC. ; burlington MA 01803
• Manufacturer (Section G): INTEGRA BURLINGTON, MA, INC.; 22 terry avenue; burlington MA 01803
• Manufacturer Contact: rowena bunuan ; 315 enterprise dr. ; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 4016060
• MDR Text Key: 4879675
• Report Number: 1222895-2014-00015
• Device Sequence Number: 1
• Product Code: GYC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K924226
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: OCS2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1