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

Catalog Number CAMCABL

Device Problems Partial Blockage (1065); Device Difficult to Setup or Prepare (1487); Out-Of-Box Failure (2311); Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A new cam02 monitor was sent for a "multi modality monitoring summit".It was noticed that the camcabl had plastic covers over the prongs and couldn't be inserted into the monitor.There was no patient contact, injury or delay in surgery.There was no patient prepped for surgery.An out of box failure was reported.

Manufacturer Narrative

Integra has completed their internal investigation on 03/29/2016.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaint history.Results: evaluation of device: during investigation, it was observed that white plastic material covering over the prongs of the 4-pin temperature connector, was cut away.Since the material blocking the prongs was cut away, the camcabl cable could be inserted into the monitor.The camcabl cable passed functional inspection to it0341 within specifications; however the cable failed visual inspection due to the damage to the temperature connector.This damage / fault to the temperature connector of the camcabl assembly (b)(4) is related to the supplier.The dhr review has been deemed satisfactory.A minimum of 12 month review of camcabl cable customer complaints was completed using the following key words ¿defective cable¿ and a root cause ¿temperature connector¿ in search criteria.This review encompassed from dates 13-nov-2014 to 22-mar-2016.A total of 23 complaints were reviewed of which 8 complaints contained the search criteria.The analysis of the complaint investigations and root cause reports has concluded this complaint is the 2nd identified complaint for the reported failure associated with the camcabl cable not functioning due to faulty temperature connector.The failure analysis investigation has concluded the cause of the cable not working was due to white plastic material covering the prongs of the 4-pin temperature connector, thus faulty temperature connector.This damage / fault to the temperature connector of the camcabl assembly (b)(4) is related to the supplier.

• Brand Name: FIBRE OPTIC CATHETER CABLE
• Type of Device: ICP MONITORING
• Manufacturer (Section D): INTEGRA NEUROSCIENCES, LTD; newbury road; newbury road; andover hampshire ; UK
• 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: 5255670
• MDR Text Key: 32406930
• Report Number: 8010219-2015-00064
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K121573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: CAMCABL
• Device Lot Number: TL-320150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/29/2016
• 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