MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-11-30 for IN LIGHT ZOOM CAMERA 0682000163 manufactured by Stryker-communications.
[32317380]
It was reported that the led in-light camera cover allegedly came off and struck a patient during a case. Account or staff didn't know that the cover had struck the patient in the case until after the patient was removed from the operating room. The patient had to have stitches where the cover struck them. The (b)(6) of the account stated that they felt that the cover coming off was due to use error and not an equipment malfunction. There have not been any adverse consequences for similar events in the past.
Patient Sequence No: 1, Text Type: N, H10
[32317381]
It was reported that the led in-light camera cover came off and struck a patient during a case. Allegedly, the patient had to have stitches where the cover struck them. The (b)(6) of the account stated that they felt that the cover coming off was user error and not a equipment malfunction. There have not been any adverse consequences for similar events in the past.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002031963-2015-00013 |
| MDR Report Key | 5255101 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-11-30 |
| Date of Report | 2015-11-03 |
| Date of Event | 2015-11-03 |
| Date Mfgr Received | 2015-11-03 |
| Date Added to Maude | 2015-11-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MR. ADAM GORZEMAN |
| Manufacturer Street | 1410 LAKESIDE PARKWAY #100 |
| Manufacturer City | FLOWER MOUND TX 75028 |
| Manufacturer Country | US |
| Manufacturer Postal | 75028 |
| Manufacturer Phone | 9724107100 |
| Manufacturer G1 | STRYKER-COMMUNICATIONS |
| Manufacturer Street | 1410 LAKESIDE PARKWAY #100 |
| Manufacturer City | FLOWER MOUND TX 75028 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75028 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IN LIGHT ZOOM CAMERA |
| Generic Name | LED IN-LIGHT CAMERA |
| Product Code | KQM |
| Date Received | 2015-11-30 |
| Catalog Number | 0682000163 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER-COMMUNICATIONS |
| Manufacturer Address | 1410 LAKESIDE PARKWAY #100 FLOWER MOUND TX 75028 US 75028 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-11-30 |