MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2019-03-18 for TCK1 HD CAMERA HEAD 242400 manufactured by Medos International Sarl.
[139108642]
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. Initial reporter phone number: (b)(6). Udi:(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[139108643]
It was reported by the affiliate via email that during the surgery by using ovb1 ccu and tck1 hd camera head, the camera stopped giving output on the screen. Additional information received form the affiliate reported that the procedure was cancelled because the camera did not work and an alternative device was not available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2019-56626 |
| MDR Report Key | 8429718 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2019-03-18 |
| Date of Report | 2019-02-18 |
| Date of Event | 2019-02-18 |
| Date Mfgr Received | 2019-03-30 |
| Date Added to Maude | 2019-03-18 |
| 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 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 | TCK1 HD CAMERA HEAD |
| Generic Name | ENDOSCOPIC VIDEO CAMERA |
| Product Code | FWF |
| Date Received | 2019-03-18 |
| Catalog Number | 242400 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Required No Informationntervention | 2019-03-18 |