MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-06 for SITUATE DETECTION SYSTEM 01-0043 manufactured by Covidien Llc.
[177966748]
We purchased these devices to detect retained objects in surgical patients, but these have been failing on a regular basis and we are not getting support from the manufacturer. Manufacturer response for counter, sponge, surgical, (situate detection system) (per site reporter). They have not been as helpful as we would like.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9676069 |
| MDR Report Key | 9676069 |
| Date Received | 2020-02-06 |
| Date of Report | 2019-11-15 |
| Date of Event | 2019-11-14 |
| Report Date | 2019-11-15 |
| Date Reported to FDA | 2019-11-15 |
| Date Reported to Mfgr | 2020-02-06 |
| Date Added to Maude | 2020-02-06 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SITUATE DETECTION SYSTEM |
| Generic Name | COUNTER, SPONGE, SURGICAL |
| Product Code | LWH |
| Date Received | 2020-02-06 |
| Returned To Mfg | 2019-11-15 |
| Model Number | 01-0043 |
| Catalog Number | 01-0043 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LLC |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-06 |