MAUDE Adverse Event Report: STRYKER ENDOSCOPY SDC3 VIDEO CAPTURE DEVICE DIGITAL DOCUMENTATION; DEVICE, DIGITAL IMAGE STORAGE, RADIOLOGICAL

Model Number SDC3

Device Problems Computer Software Problem (1112); Loss of Data (2903)

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

Event Date 06/23/2016

Event Type  malfunction  

Event Description

During surgery, the sdc video capture device was used to save numerous photos of the surgery.Photos are used to document procedure and become part of the patient's medical record.Photos may be needed to get reimbursement for some procedures.At the end of surgery, it was discovered that most of the photos were not captured.We have been having an abnormally high failure rate of the dvi video input boards on these units.In one area, 7 out of 8 have failed.There have been several documented delays during surgery caused by failures of the recording device.Not related to the dvi input, we have also had problems with the software becoming corrupted if the unit loses ac power, like during the emergency generator test.In most cases this can be corrected by reloading the software.Software version is 1.3.1.We believe the version hasn't changed since we bought these.We think this is mainly a hardware issue with the dvi input board.Manufacturer response for video capture device, (brand not provided) (per site reporter): the dvi input board failed and needs to be replaced.

• Brand Name: SDC3 VIDEO CAPTURE DEVICE DIGITAL DOCUMENTATION
• Type of Device: DEVICE, DIGITAL IMAGE STORAGE, RADIOLOGICAL
• Manufacturer (Section D): STRYKER ENDOSCOPY; 5900 optical court; san jose CA 95138
• MDR Report Key: 5761049
• MDR Text Key: 48515543
• Report Number: 5761049
• Device Sequence Number: 1
• Product Code: LMB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: SDC3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/27/2016
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/27/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1