MAUDE Adverse Event Report: STRYKER ENDOSCOPY SDC3; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Device Problems Poor Quality Image (1408); Defective Component (2292)

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

Event Date 03/15/2019

Event Type  malfunction  

Event Description

The digital capture device that goes into the camera malfunctioned during the procedure causing odd images to appear on the screen.Striker representative came to inspect the device and recommended a replacement.

• Brand Name: SDC3
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY; 5900 optical ct; san jose CA 95138
• MDR Report Key: 8431544
• MDR Text Key: 139225181
• Report Number: 8431544
• Device Sequence Number: 0
• Product Code: GCJ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/15/2019
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 03/19/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18250 DA