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 2019-04-11 for OVB1 CAMERA CONTROL UNIT 242300 manufactured by Medos International Sarl.
[141662291]
Product complaint #: (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(6). Udi: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[141662292]
It was reported by the affiliate via email that the ovb1 camera control unit in between the surgery, the camera stopped giving output on the screen. Additional information provided by the affiliate reported that the camera control unit stopped working during the procedure. The procedure was cancelled due to this malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2019-56790 |
| MDR Report Key | 8505981 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-11 |
| Date of Report | 2019-03-13 |
| Date of Event | 2019-01-01 |
| Date Mfgr Received | 2019-05-07 |
| Date Added to Maude | 2019-04-11 |
| 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 | 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 SARL |
| 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 | ENDOSCOPIC VIDEO IMAGE PROCESSOR |
| Product Code | FWF |
| Date Received | 2019-04-11 |
| Catalog Number | 242300 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDOS INTERNATIONAL SARL |
| Manufacturer Address | CHEMIN-BLANC 38 LE LOCLE 02400 SZ 02400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-11 |