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 2018-11-30 for TCK1 HD CAMERA HEAD 242400 manufactured by Medos International Sàrl.
[128944781]
If additional information should become available, a supplemental medwatch will be submitted accordingly. Udi: (b)(4). As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[128944782]
It was reported by the affiliate in (b)(6) that pre-surgery to an unspecified surgical procedure, it was observed that the camera head device was not getting detected on switching on the ccu and monitor. It was not reported if there was a delay in the surgical procedure. It was reported that a spare device was available for use. It was reported if the procedure was completed. It was not reported if there was a delay in the surgical procedure or if a spare device was available for use. There was no patient involvement. There were no reports of injuries, medical intervention or prolonged hospitalization. The exact date of this event was unknown but was noted to have occurred in 2018. All available information has been disclosed. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
[131494448]
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Evaluation statement: the device was received at service center and evaluated. The complaint is confirmed. As per the service report it is checked and found the camera head is not sensed by ccu and complaint device is not repairable. The root cause for the reported problem is undetermined. No nonconformances were identified for this part number 242400, serial number (b)(4) combination. At this point, 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). Corrected data: date device returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[131494449]
Additional information received from affiliate on 18november2018: the issues was detected pre-operatively on (b)(6) 2018. There was no procedure or patient impact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2018-55486 |
| MDR Report Key | 8121413 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-11-30 |
| Date of Report | 2018-10-22 |
| Date of Event | 2018-07-31 |
| Date Mfgr Received | 2018-12-26 |
| Date Added to Maude | 2018-11-30 |
| 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 S RL |
| 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 | 2018-11-30 |
| Returned To Mfg | 2018-10-29 |
| Catalog Number | 242400 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-11-30 |