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

Model Number 0240060100

Device Problems No Display/Image (1183); Application Program Problem (2880)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2022

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.

Event Description

It was reported that the device lost image for 10 minutes during a procedure.There was no report of adverse consequences as a result.

Manufacturer Narrative

Alleged failure: (b)(6) medical center: (b)(6) called in advising or 17 sdc crashed during a case and wouldn't come up for 10 minutes.Sn: (b)(6).This is a coros room.Work order# (b)(4): salesforce case number (b)(4).The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root cause(s) could be software failure.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.

Event Description

It was reported that the device lost image for 10 minutes during a procedure.There was no report of adverse consequences as a result.

• 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
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: benjamin ly ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 15422886
• MDR Text Key: 305788408
• Report Number: 0002936485-2022-00519
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 07613327056150
• UDI-Public: 07613327056150
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 0240060100
• Device Catalogue Number: 0240060100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/31/2022
• Initial Date FDA Received: 09/14/2022
• Supplement Dates Manufacturer Received: 08/31/2022
• Supplement Dates FDA Received: 11/09/2022
• 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: Reuse
• Patient Sequence Number: 1