MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-11-13 for KARLIN CERVICAL CURETTE, 10.5" FORWARD ANGLE SP01462-563 manufactured by Symmetry Surgical.
[16453508]
The curette cup broke when being used. The piece of the curette cup that severed from the curette was retrieved and there was no injury to the pt.
Patient Sequence No: 1, Text Type: D, B5
[16847057]
Device record for the mfg of the device was reviewed. It showed a cutting test and that hardness testing was performed at final inspection.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007208013-2013-00009 |
| MDR Report Key | 3554505 |
| Report Source | 07 |
| Date Received | 2013-11-13 |
| Date of Report | 2013-06-04 |
| Date of Event | 2013-06-04 |
| Date Mfgr Received | 2013-06-06 |
| Device Manufacturer Date | 2013-05-01 |
| Date Added to Maude | 2014-02-19 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 3034 OWEN DR |
| Manufacturer City | ANTIOCH TN 37013 |
| Manufacturer Country | US |
| Manufacturer Postal | 37013 |
| Manufacturer Phone | 8002513000 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KARLIN CERVICAL CURETTE, 10.5" FORWARD ANGLE |
| Product Code | GZX |
| Date Received | 2013-11-13 |
| Model Number | SP01462-563 |
| Lot Number | SO1133 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYMMETRY SURGICAL |
| Manufacturer Address | ANTIOCH TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-13 |