MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-07-17 for ATAR D-IS1 2PACE DISPOSABLE EXTENSION CABLE ATAR D-IS1-2PACE manufactured by Oscor Inc..
[80276359]
The conclusion is not yet available, the evaluation is in process. This initial mdr is being submitted to meet our requirements of reporting. A follow-up will be submitted as soon as the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[80276360]
The set screw on the is-1 receptacle portion of the extension did not engage as intended.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1035166-2017-00057 |
| MDR Report Key | 6720177 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-07-17 |
| Date of Report | 2018-06-06 |
| Date of Event | 2017-04-20 |
| Date Mfgr Received | 2017-10-13 |
| Device Manufacturer Date | 2017-03-23 |
| Date Added to Maude | 2017-07-17 |
| 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 | MS DORIT SEGAL |
| Manufacturer Street | 3816 DESOTO BLVD |
| Manufacturer City | PALM HARBOR FL 346831816 |
| Manufacturer Country | US |
| Manufacturer Postal | 346831816 |
| Manufacturer Phone | 7279372511 |
| Manufacturer G1 | OSCOR INC |
| Manufacturer Street | 3816 DESOTO BLVD |
| Manufacturer City | PALM HARBOR FL 346831816 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 346831816 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ATAR D-IS1 2PACE DISPOSABLE EXTENSION CABLE |
| Generic Name | CABLE, ELECTRODE |
| Product Code | IKD |
| Date Received | 2017-07-17 |
| Returned To Mfg | 2017-06-19 |
| Model Number | ATAR D-IS1-2PACE |
| Catalog Number | ATAR D-IS1-2PACE |
| Lot Number | C3-17404 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSCOR INC. |
| Manufacturer Address | 3816 DESOTO BLVD. PALM HARBOR FL 346831816 US 346831816 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-17 |