MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-04-10 for CAMERA HEAD AC - C-MOUNT 242401 manufactured by Medos International Sarl.
[145918921]
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. Udi: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[145918922]
It was reported by the customer that during a lap coli the camera head ac c-mount image is cutting out. The procedure was completed with a different camera with no patient harm but there was a surgical delay of 10 minutes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2019-56806 |
| MDR Report Key | 8500436 |
| Report Source | OTHER |
| Date Received | 2019-04-10 |
| Date of Report | 2019-03-14 |
| Date of Event | 2019-03-14 |
| Date Mfgr Received | 2019-05-13 |
| Date Added to Maude | 2019-04-10 |
| 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 |
| Manufacturer Country | SZ |
| 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 | CAMERA HEAD AC - C-MOUNT |
| Generic Name | ENDOSCOPIC VIDEO CAMERA |
| Product Code | FWF |
| Date Received | 2019-04-10 |
| Returned To Mfg | 2019-04-29 |
| Catalog Number | 242401 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2019-04-10 |