MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES, LTD. FIBRE OPTIC CATHETER CABLE; ICP MONITORING

Catalog Number CAMCABL

Device Problems Bent (1059); Out-Of-Box Failure (2311)

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

Event Type  malfunction  

Event Description

The pin was damaged/bent.Out of box failure.There was no pt contact no pt prepped for surgery, no pt injury and no delay in surgery.

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

Integra has completed their internal investigation on 11/23/2015.The investigation included: methods: review of device history records, review of complaints history.Results: dhr review was completed for camcabl cable serial number (b)(4), work order 232079, lot number tl-319943 manufactured in tullamore, ireland, to identify any recorded anomalies that could be associated to the complaint incident.Date of manufacture: oct-2014.The dhr review has been deemed satisfactory.A minimum of 12 month review of camcabl monitor customer complaints was completed in trackwise® using the following key words ¿defective cable¿ and a root cause ¿product not returned¿ in search criteria.The key word search review of the complaints contained all and/or part of the key words to complete a comprehensive trend review.The analysis of the complaint investigations and root cause reports has concluded this is the 2nd identified complaint for the reported failure associated with the camcabl cable that has not been returned for evaluation.No trend has been identified.No review of non-conformance reports (ncrs) is deemed necessary as the root cause of the complaint incident was not determined.Conclusion: since the product was not returned for failure analysis investigation no root cause can be established.

Manufacturer Narrative

Integra has completed their internal investigation on 1/28/2016.The investigation included: methods: evaluation of actual device.Review of complaint history.Results: evaluation of device: although the camcabl cable passed functional inspection within specifications, it failed visual inspection due to teflon section surrounding the pin on the temperature connector was protruding far past the pin.This fault can be concluded due to physical damage to the cable.A review of complaints history revealed no trend identified.Conclusion: the customer complaint incident ¿pin is damaged / bent¿ was verified and duplicated.The root cause determined to be the teflon section surrounding the pin on the temperature connector protruding far past the pin, concluded as physical damage.

• Brand Name: FIBRE OPTIC CATHETER CABLE
• Type of Device: ICP MONITORING
• Manufacturer (Section D): INTEGRA NEUROSCIENCES, LTD.; andover hampshire SP104 DR; UK SP104DR
• Manufacturer (Section G): INTEGRA NEUROSCIENCES, LTD; newbury road; andover hampshire ; UK
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 4733261
• MDR Text Key: 18070651
• Report Number: 8010219-2015-00021
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 04/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2015
• 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: TL-319943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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