MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-11 for CAMERA HEAD AC - C-MOUNT 242401 manufactured by Medos International Sarl.
[187076272]
Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Additional narrative: udi: (b)(4). Investigation summary ==> the device was received and evaluated at the service center. The reported complaint from the customer that the camera head did not work was confirmed. The device was tested and found that it does not power up. Also the camera head did not recognize the accessory device connected to it. The device was deemed non-repairable, so the repair was declined and the device was placed into long term hold. Given the information provided we cannot discern a definitive root cause for the identified failures. A manufacturing record evaluation was performed for the finished device (serial number : (b)(4)), and no non-conformances were identified. At this point in time, no corrective action is required, and no further action is warranted. 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. Device history lot ==> a manufacturing record evaluation was performed for the finished device (serial number : (b)(4)), and no non-conformances were identified.
Patient Sequence No: 1, Text Type: N, H10
[187076273]
It was reported by the sales rep that during an unspecified surgical procedure, it was observed that the camera head device did not work. The sales rep tried repeatedly plugging and unplugging without success. A new camera head was used and it worked normally. No patient consequences or surgical delay reported. There were no reports of injuries, medical intervention or prolonged hospitalization. During in-house engineering evaluation, it was determined that the device did not power up when tested. All available information has been disclosed. If additional information should become available, a supplemental medwatch will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2020-00829 |
| MDR Report Key | 9820112 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-11 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-01-23 |
| Date Mfgr Received | 2020-03-10 |
| Date Added to Maude | 2020-03-11 |
| 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 | 6013142063 |
| Manufacturer G1 | MEDOS INTERNATIONAL SARL |
| Manufacturer Street | CHEMIN BLANC 38 |
| Manufacturer City | LE LOCLE CH-2400 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH-2400 |
| 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 | 2020-03-11 |
| Returned To Mfg | 2020-02-18 |
| Model Number | 242401 |
| Catalog Number | 242401 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDOS INTERNATIONAL SARL |
| Manufacturer Address | CHEMIN BLANC 38 LE LOCLE CH-2400 SZ CH-2400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-11 |