MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-05-09 for OVB1 CAMERA CONTROL UNIT 242300 manufactured by Medos International Sàrl.
[145635256]
If additional information should become available, a supplemental medwatch will be submitted accordingly. (b)(4). As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. If information is obtained that was not available for the initial medwatch, a follow-up medwatch.
Patient Sequence No: 1, Text Type: N, H10
[145635257]
This is report 1 of 2 for the same event. It was reported by the affiliate in (b)(6) via e-mail that during laparoscopy, it was observed that the image would go off completely during manipulation of the camera; and then the green indicator that showed that the camera was working would go off when the image disappeared but then the image would come on again. It was further reported that the base unit would sometime automatically go off although the image may still be seen but the photo also did not get captured. As a result, there was a surgical delay of half an hour as a standby system was available for use. The surgery was not completed as the device has shifted from the other center. There was patient involvement reported. There were no injuries, medical intervention or prolonged hospitalization. All available information has been disclosed. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2019-57100 |
| MDR Report Key | 8594757 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-09 |
| Date of Report | 2019-04-22 |
| Date of Event | 2019-04-18 |
| Date Mfgr Received | 2019-04-22 |
| Date Added to Maude | 2019-05-09 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | MEDOS INTERNATIONAL S RL |
| Manufacturer Street | CHEMIN-BLANC 38 |
| Manufacturer City | LE LOCLE 02400 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 02400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OVB1 CAMERA CONTROL UNIT |
| Generic Name | EDNOSCOPIC VIDEO IMAGE PROCESSOR |
| Product Code | FWF |
| Date Received | 2019-05-09 |
| Catalog Number | 242300 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDOS INTERNATIONAL SàRL |
| Manufacturer Address | CHEMIN-BLANC 38 LE LOCLE 02400 SZ 02400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-09 |