MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-03-29 for S-L,HLCL,3.0,4W,11,090,0T ,R 5700006 manufactured by Gyrus Acmi, Inc.
[140315943]
The referenced device was not returned to olympus for evaluation. The exact cause of the reported event cannot be confirmed. If the device is returned at a later date, this report will be supplemented accordingly. A review of the dhr for this product has been conducted and all records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.
Patient Sequence No: 1, Text Type: N, H10
[140315944]
Olympus was informed that during the middle to the end of a therapeutic cystoscopy with removal of a right ureteral stent, the patient had a large, hard stone that required fragmentation for removal. The basket broke when it was removed from the patient. There were no device fragments that broke off or fell into the patient. There was no bleeding reported. A second device from the same lot was used and also broke. The procedure was completed using a third device from a different lot. There was patient injury reported. 2 of 2 devices
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00583 |
| MDR Report Key | 8463250 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-29 |
| Date of Report | 2019-07-30 |
| Date of Event | 2018-12-12 |
| Date Mfgr Received | 2019-04-23 |
| Date Added to Maude | 2019-03-29 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | S-L,HLCL,3.0,4W,11,090,0T ,R |
| Generic Name | SURLOK HELICAL STONE BASKET |
| Product Code | FGO |
| Date Received | 2019-03-29 |
| Model Number | 5700006 |
| Lot Number | MK715070 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-29 |