MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-02-12 for OVB1 CAMERA CONTROL UNIT 242300 manufactured by Medos International Sarl.
[135942938]
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). Investigation summary: the device was sent to the service center for repair. The work order indicates that a defective isolation board was found. It was replaced and the device testing passed. The defective board is the root cause of this failure. No further information regarding the cause of the defect has been provided to help determine a root cause for this failure. This complaint can be confirmed. At this point in time, no corrective action is required, and no further action is warranted. However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[135942939]
It was reported by the affiliate via email that their ovb1 camera had stopped giving output on its screen during the surgery. Additional information provided by the affiliate on 01/15/19 reporting that there was a surgical delay of 20 to 30 minutes and the surgery had to be called off due to the malfunction. Additional information provided by the affiliate on 01/16/19 stating that the patient was already under anesthesia when the procedure was cancelled.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2019-56383 |
| MDR Report Key | 8332975 |
| Report Source | FOREIGN |
| Date Received | 2019-02-12 |
| Date of Report | 2019-01-16 |
| Date of Event | 2018-12-10 |
| Date Mfgr Received | 2019-01-16 |
| Date Added to Maude | 2019-02-12 |
| 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 DR |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | MEDOS INTERNATIONAL SàRL |
| 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 | 2019-02-12 |
| Returned To Mfg | 2019-01-29 |
| Catalog Number | 242300 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-02-12 |