MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SERVICE CCU HIGH DEF 560P 2NDGEN; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 72201919S

Device Problem Loss of Power (1475)

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

Event Date 08/24/2018

Event Type  malfunction  

Event Description

It was reported that the color went grey then the device blacked out.There was a surgical delayr greater than 30 minutes.The procedure was completed with a backup device with no patient injury reported.

Manufacturer Narrative

The device was received for evaluation.A visual inspection was performed on the product and no issue was observed.There was a relationship found between the returned device and the reported incident.Ccu failed functional testing with blank video output.Cause of output malfunction is a defective electronic component on the video processor pcb.Product passed functional testing with a known good video processor pcb installed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.

• Brand Name: SERVICE CCU HIGH DEF 560P 2NDGEN
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 7881855
• MDR Text Key: 120696528
• Report Number: 1643264-2018-00719
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 03596010645517
• UDI-Public: (01)03596010645517
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070266
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72201919S
• Device Catalogue Number: 72201919S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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