MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-16 for RF ASSURE DETECTION SYSTEM G0804-12P02C-1 manufactured by Rf Surgical.
[40782352]
(b)(4). To date the sample has not been received for evaluation. If the sample is received or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[40782353]
The customer reported that there were small pieces of thread falling off the sponges into the sterile field which were removed. The sponge remained intact. Not every sponge in every pack is shredding about half in the pack. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005883396-2016-00008 |
| MDR Report Key | 5505131 |
| Date Received | 2016-03-16 |
| Date of Report | 2016-02-19 |
| Date Mfgr Received | 2016-02-19 |
| Device Manufacturer Date | 2015-07-02 |
| Date Added to Maude | 2016-03-16 |
| 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 | SHARON MURPHY |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | RF SURGICAL |
| Manufacturer Street | 5927 LANDAU COURT |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92008 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RF ASSURE DETECTION SYSTEM |
| Generic Name | RF DETECT GAUZE |
| Product Code | EFQ |
| Date Received | 2016-03-16 |
| Catalog Number | G0804-12P02C-1 |
| Lot Number | 150702K |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RF SURGICAL |
| Manufacturer Address | 5927 LANDAU COURT CARLSBAD CA 92008 US 92008 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-16 |