MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-30 for SDC3 VIDEO CAPTURE DEVICE DIGITAL DOCUMENTATION manufactured by Stryker Endoscopy.
[48515542]
Patient Sequence No: 1, Text Type: N, H10
[48515543]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5761049 |
| MDR Report Key | 5761049 |
| Date Received | 2016-06-30 |
| Date of Report | 2016-06-27 |
| Date of Event | 2016-06-23 |
| Report Date | 2016-06-27 |
| Date Reported to FDA | 2016-06-27 |
| Date Reported to Mfgr | 2016-06-27 |
| Date Added to Maude | 2016-06-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SDC3 VIDEO CAPTURE DEVICE DIGITAL DOCUMENTATION |
| Generic Name | DEVICE, DIGITAL IMAGE STORAGE, RADIOLOGICAL |
| Product Code | LMB |
| Date Received | 2016-06-30 |
| Returned To Mfg | 2016-06-23 |
| Model Number | SDC3 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ENDOSCOPY |
| Manufacturer Address | 5900 OPTICAL COURT SAN JOSE CA 95138 US 95138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-30 |