MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERELINK ICP EXT CABLE; CERELINK - CABLES

Model Number	HRAIM
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The cerelink cable was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.However, the possible root cause for the issue reported by the customer could be due to inappropriate technique for assembly and use of the device.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
This is 1 of 2 reports linked to mfg report numbers: 3014334038-2022-00051.Same patient, same event, different products.A facility reported a cerelink sensor was placed in the operating room (or) and was working fine.The patient was disconnected from the monitor, placed on a transport bed, brought to post anesthesia care unit (pacu).In the pacu it repeatedly got a sensor/cable failure error.They replaced the cable and monitor for three times.They kept the sensor in the patient overnight.It was a tunneled basic sensor.They tried the cerelink overnight with no success.Troubleshooting was done in the morning and tried it in an icpx with a reference code of 500 to see if the sensor would work, however, sensor was not acknowledged.The patient went back to the or, back under anesthesia, the sensor was removed and was not replaced.

• Brand Name: CERELINK ICP EXT CABLE
• Common Device Name: CERELINK - CABLES
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 14946034
• Report Number: 3013886523-2022-00314
• Device Sequence Number: 17282568
• Product Code: GWM
• UDI-Device Identifier: 10381780252283
• UDI-Public: 10381780252283
• Combination Product (Y/N): N
• PMA/510(K) Number: K210993
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/07/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: HRAIM
• Device Catalogue Number: 826845
• Device Lot Number: 142944
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2022
• Initial Report FDA Received Date: 07/07/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown