MAUDE Adverse Event Report: INTEGRA NEUROLIFECIENCES (IRELAND), LTD. SRAGH, TULLAMORE, CO. FIBRE OPTIC CATHETER CABLE; ICP MONITORING

Catalog Number CAMCABL

Device Problems Defective Component (2292); Connection Problem (2900)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 04/03/2015

Event Type  malfunction  

Event Description

It was reported that a camcabl fibre optic cable has a defective connector.Additional information has been requested.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information received was described as follows, "no, the unit was not in contact with a patient".If there was contact please provide the patients' age, gender and underlying medical condition - n/a.The date of the event: (b)(6) 2015.What type of procedure was being performed? - none.Was the procedure delayed a result of this issue? n/a.If so, how long was it delayed? n/a.Did the patient incur an injury as a result of this delay or issue? n/a.If so, please described the injury and how it was treated: n/a.When was the defective connector found to be damaged? (b)(6) 2015.Was it received damaged directly from the manufacturer? no.Or was it found defective dunng set up or during a procedure? no answer was provided.Is it known how the connector became damaged? normal usage.

Manufacturer Narrative

Integra has completed their internal investigation on 10/19/2015.The investigation included: methods: evaluation of actual device, review of device history records, review of complaints history.Results: the customer complaint incident ¿defective connector¿ was verified and duplicated.Dhr review was completed for camcabl cable serial number (b)(4), work order (b)(4), date of manufacture: mar-2014.No non-conformance reports were raised during the manufacturing process for this cable.The dhr review has been deemed satisfactory.Trending analysis was completed by the root cause identified in the failure analysis investigation.Complaint history review encompassed dates 13-apr-2014 to 14-oct-2015; the analysis of the complaint investigations and root cause reports has concluded this is the 1st identified camcabl cable complaint for the reported failure with the root cause determined as poor maintenance.No trend has been identified.No further actions are deemed necessary.Conclusion: the failure analysis investigation has concluded the cause of the defective connector was due to misuse which is consistent with the poor maintenance of the cable by the user.

• Brand Name: FIBRE OPTIC CATHETER CABLE
• Type of Device: ICP MONITORING
• Manufacturer (Section D): INTEGRA NEUROLIFECIENCES (IRELAND), LTD. SRAGH, TULLAMORE, CO.; offaly ; EI
• Manufacturer (Section G): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer Contact: linda serentino ; 315 enterprise dr; 6099365560
• MDR Report Key: 4745348
• MDR Text Key: 21081168
• Report Number: 8010219-2015-00023
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CAMCABL
• Device Lot Number: 543048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/06/2015
• Initial Date FDA Received: 04/30/2015
• Supplement Dates Manufacturer Received: 10/19/2015; 10/19/2015
• Supplement Dates FDA Received: 05/27/2015; 11/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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