MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-25 for RAPIDCLEAN KERRISON RONGEUR 53-1624LD 53-1627LED manufactured by Symmetry Surgical Inc.
[121861128]
The pin fell out of the instrument, this came to their attention when the surgeon noticed the pin laying on the sterile drape next to the site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007208013-2018-00007 |
| MDR Report Key | 7905832 |
| Date Received | 2018-09-25 |
| Date of Report | 2018-10-15 |
| Date of Event | 2018-08-31 |
| Date Facility Aware | 2018-10-04 |
| Date Mfgr Received | 2018-10-04 |
| Date Added to Maude | 2018-09-25 |
| 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. VICTORIA ROGERS |
| Manufacturer Street | 3034 OWEN DRIVE |
| Manufacturer City | ANTIOCH TN 37013 |
| Manufacturer Country | US |
| Manufacturer Postal | 37013 |
| Manufacturer Phone | 8002513000 |
| Manufacturer G1 | SYMMETRY SURGICAL INC |
| Manufacturer Street | 3034 OWEN DRIVE |
| Manufacturer City | ANTIOCH TN 37013 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37013 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RAPIDCLEAN KERRISON RONGEUR |
| Generic Name | RONGEUR |
| Product Code | HAE |
| Date Received | 2018-09-25 |
| Returned To Mfg | 2018-10-04 |
| Model Number | 53-1624LD |
| Catalog Number | 53-1627LED |
| Lot Number | 20141951 |
| Device Availability | R |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYMMETRY SURGICAL INC |
| Manufacturer Address | 3034 OWEN DRIVE ANTIOCH TN 37013 US 37013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-25 |