MAUDE Adverse Event Report: INTEGRA BURLINGTON, MA, INC. OJEMAN CORTICAL STIMULATOR; N/A

Catalog Number OCS2

Device Problems No Device Output (1435); Out-Of-Box Failure (2311); Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A report was received that on (b)(6) 2015, the ocs2 ojeman cortical stimulator had no output current.It was reported that it was an out of box failure (device was purchased on (b)(6) 2015) and it was unknown if the device was in contact with a patient.When it was tested, there was no output current.The batteries were changed and the battery indicator on the unit was at the highest level.A revision/medical intervention was required however details were not provided at the time of this report.The patient was prepped for surgery and there was delay in surgery due to the product problem however the amount of time was not provided.The device had been used approximately 6-8 times since being purchased and received.Additional information was requested.

Manufacturer Narrative

Integra has completed their internal investigation on 09 aug 2016.The investigation included: methods: evaluation of actual device, review of device history records, review of complaint history.Results: evaluation of device: one oc2 was received in billerica on 05/13/2016.The serial number was reported as being (b)(4) which was incorrect, the correct serial number is (b)(4).A visual inspection of the returned product found visual damage on both the front and back left corners of the ocs2.Customer states the unit has no output reading.This issue is due to the transformer breaking off of the printed circuit board.The printed circuit board cannot be repaired - will require replacement board before calibrating the dhr review verified all the functionality tests were carried out accordingly and all results of the tests were recorded as within specification prior to the ocs2 been released.No nonconformance reports were raised during the manufacturing process for these monitors.Manufacture date: dec-2007.A two year complaint look back was performed in trackwise for the ocs2.In the prior two years, 21 complaint, including this complaint, have been received on the ocs2.No additional complaints were received with the reported failure ¿no output current".No adverse trend is identified at this time.Conclusion: the internal component coming loose was likely caused by physical damage to the unit.The ocs2 was repaired, recalibrated and returned to the customer.

• Brand Name: OJEMAN CORTICAL STIMULATOR
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA BURLINGTON, MA, INC.; 22 terry avenue; 22 terry avenue; burlington MA 01803
• Manufacturer (Section G): INTEGRA BURLINGTON, MA, INC.; 22 terry avenue; burlington MA 01803
• Manufacturer Contact: bina patel ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5660701
• MDR Text Key: 46583405
• Report Number: 1222895-2016-00005
• Device Sequence Number: 1
• Product Code: GYC
• Combination Product (y/n): N
• PMA/PMN Number: K924226
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2016
• 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: 05/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2007
• 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