MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2019-03-28 for TCK1 HD CAMERA HEAD 242400 manufactured by Medos International Sarl.
[140176268]
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Investigation summary: the device was received at service center and evaluated. Per service manual operational and diagnostic analysis confirmed reported issue of the image cutting out. The device would intermittently not display video or would display poor quality video. However,the root cause for the reported failure is undetermined. There is no repair authorized for this device, so the device will be placed into long term hold with no further repair activities taking place. Furthermore, no non-conformances were identified for this part number (242400), serial number ((b)(4)) combination. Review conducted per qlik query executed on (b)(6)2019. At this point in time, no corrective action is required, and no further action is warranted. However, depuy 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
[140176269]
It was reported by the sales rep via phone that during a shoulder repair procedure the customer's tck1 camera head had poor image quality and the image was cutting out. The case was completed with another like-device with no patient harm or delay. The device is being returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2019-56700 |
| MDR Report Key | 8460252 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2019-03-28 |
| Date of Report | 2019-03-26 |
| Date of Event | 2018-12-06 |
| Date Mfgr Received | 2019-03-26 |
| Date Added to Maude | 2019-03-28 |
| 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 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 | 2019-03-28 |
| Returned To Mfg | 2018-12-17 |
| Catalog Number | 242400 |
| 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 | 2019-03-28 |