MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE SDC3 BASE SYSTEM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 0240060100

Device Problem Loss of Power (1475)

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

Event Date 06/12/2020

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Event Description

It was reported that there was image loss, multiple times during procedure.The procedure was completed successfully with no reports of adverse consequences.

Event Description

It was reported that there was image loss, multiple times during procedure.The procedure was completed successfully with no reports of adverse consequences.

Manufacturer Narrative

Alleged failure: eib alex onsite shuts off byt itself po# (b)(4).In the middle of a case, sdc3 would shut off mid case for no reason.Happened multiple times after restarting.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root cause/s could be (1) dust was collected on the cpu fan causing the cpu to overheat (2) insufficient air ventilation (3) power cable was loose (4) power source or power surge issue.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• Brand Name: SDC3 BASE SYSTEM
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10258077
• MDR Text Key: 199054685
• Report Number: 0002936485-2020-00268
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 07613327056150
• UDI-Public: 07613327056150
• Combination Product (y/n): N
• PMA/PMN Number: K160332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 09/01/2020

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 Model Number: 0240060100
• Device Catalogue Number: 0240060100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Initial Date Manufacturer Received: 06/12/2020
• Initial Date FDA Received: 07/10/2020
• Supplement Dates Manufacturer Received: 06/12/2020
• Supplement Dates FDA Received: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1