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 2019-03-11 for TCK1 HD CAMERA HEAD 242400 manufactured by Medos International Sàrl.
[138380868]
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)(4).
Patient Sequence No: 1, Text Type: N, H10
[138380869]
It was reported by the affiliate that thetck1 hd camera head image is flickering intermittently and color bars are appearing. The event occurred pre-operatively. The intended procedure was a turp. There was no surgical delay or patient consequences. The existing camera was used to complete the procedure; an alternate product was readily available. No surgical intervention is planned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2019-56601 |
| MDR Report Key | 8407826 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-11 |
| Date of Report | 2019-01-21 |
| Date of Event | 2019-01-20 |
| Date Mfgr Received | 2019-10-26 |
| Date Added to Maude | 2019-03-11 |
| 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 |
| 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 | 5089776860 |
| Manufacturer G1 | MEDOS INT MITEK |
| Manufacturer Street | CHEMIN BLANC 38 |
| Manufacturer City | LE LOCLE |
| Manufacturer Country | SZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TCK1 HD CAMERA HEAD |
| Generic Name | ENDOSCOPIC VIDEO CAMERA |
| Product Code | FWF |
| Date Received | 2019-03-11 |
| Returned To Mfg | 2019-01-28 |
| Catalog Number | 242400 |
| 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 SàRL |
| Manufacturer Address | CHEMIN-BLANC 38 LE LOCLE 02400 SZ 02400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-11 |