MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-01-24 for RIGID 3 PRONG GRASPER FOR RETRIEVAL OF STONES RPG-437 manufactured by Gyrus Acmi Inc.
[4174699]
Olympus received a medwatch form from the user facility, which states that during a percutaneous nephrostolithotomy of a large and calcified stone, the prongs spontaneously broke from the grasper. The surgeon was using the grasper forceps while dissolving the stone while a laser when the prongs broke. The pieces were retrieved from the patient, and the procedure was completed with an unidentified device. There was no patient harm reported.
Patient Sequence No: 1, Text Type: D, B5
[11492466]
The device referenced in this report was not returned to olympus for evaluation, as it has been discarded by the user facility after the procedure. The exact cause of the user's report could not be conclusively determined. If additional and relevant information becomes available later, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951238-2014-00029 |
| MDR Report Key | 3606675 |
| Report Source | 05,06 |
| Date Received | 2014-01-24 |
| Date of Report | 2014-01-08 |
| Date of Event | 2013-09-17 |
| Date Mfgr Received | 2014-01-08 |
| Date Added to Maude | 2014-03-31 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LAURA STORMS |
| Manufacturer Street | 2400 RINGWOOD AVE. |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4848965688 |
| Manufacturer G1 | GYRUS ACMI INC |
| Manufacturer Street | 136 TURNPIKE RD |
| Manufacturer City | SOUTHBOROUGH MA 01772210 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01772 2104 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RIGID 3 PRONG GRASPER FOR RETRIEVAL OF STONES |
| Generic Name | RIGID 3 PRONG GRASPING FORCEPS |
| Product Code | JEK |
| Date Received | 2014-01-24 |
| Model Number | RPG-437 |
| Catalog Number | RPG-437 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI INC |
| Manufacturer Address | 136 TURNPIKE RD SOUTHBOROUGH MA 01772210 US 01772 2104 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-24 |