MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-03 for SWITCHPOINT INFINITY 0678001000 0678-001-000 manufactured by Stryker Communications Inc..
[88053464]
Patient Sequence No: 1, Text Type: N, H10
[88053465]
Stryker is using a very poor quality dvi connector for their video integration system. This type of connector keeps breaking very often, almost weekly. They are using a dvi connector that is not intended to be used for the amount of mechanical work that it is used for. We have 13 operating rooms in our facility and we replace this connector almost weekly. They break because they cannot withstand the weight of the cables that are used and also the amount of times that the dvi connector needs to be used on the daily basis. Manufacturer response for video integration system, (per site reporter): they have replaced the connector multiple times, but haven't come up with a solution.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6910415 |
| MDR Report Key | 6910415 |
| Date Received | 2017-10-03 |
| Date of Report | 2017-09-29 |
| Date of Event | 2016-06-01 |
| Report Date | 2017-09-29 |
| Date Reported to FDA | 2017-09-29 |
| Date Reported to Mfgr | 2017-09-29 |
| Date Added to Maude | 2017-10-03 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | SWITCHPOINT INFINITY |
| Generic Name | ENDOSCOPIC VIDEO IMAGING SYSTEM/COMPONENT, GASTROENTEROLOGY-UROLOGY |
| Product Code | OCS |
| Date Received | 2017-10-03 |
| Model Number | 0678001000 |
| Catalog Number | 0678-001-000 |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER COMMUNICATIONS INC. |
| Manufacturer Address | 571 SILVERON BLVD. FLOWER MOUND TX 75028 US 75028 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-03 |