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 2019-02-06 for FLEX-CATCH 4 WIRE NITINOL BASKET NT4F19115 manufactured by Gyrus Acmi, Inc.
[137440129]
The referenced device was not returned to olympus for evaluation. The exact cause of the reported event cannot be determined; however, the mostly likely cause of the reported event can potentially be attributed to a higher than normal force applied on the joint by the operator when extracting a large stone. The instruction manual warns users: certain objects may be too large to remove endoscopically with this retrieval system. To avoid complications fluoroscopic x-ray or some means of identification of an objects size should be used prior to attempting to remove. Do not use this device if the object is too large to be removed and/or cannot be securely held in the stone dislodger. Inspect the device for any visible damage such as kinks or broken stone dislodger wires. Test the device by opening, closing and rotating it several times before being introduced into the patient. If the device is returned at a later date, this report will be supplemented accordingly.
Patient Sequence No: 1, Text Type: N, H10
[137440130]
Olympus was informed that during a cystoscopy/ureteroscopy and lithotripsy procedure, the doctor was performing a ureteral stone removal when the wire basket of the device broke. The breakage occurred after stone fragmentation and during the stone fragment extraction. The user facility reported there was no issue withdrawing the device and no device fragments fell into the patient as the stone basket remained within the ureteral access sheath. The user facility reported the patient had some minor bleeding; no treatment needed as it was reported to be minor and likely subsided on its own. In addition, the remaining stones were unable to be retrieved so the patient will require a second procedure and will be scheduled at a later date. No medical or surgical intervention was required and the patient did not require a longer stay. It is unknown if the device was inspected prior to procedure. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00424 |
| MDR Report Key | 8313584 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-02-06 |
| Date of Report | 2019-03-19 |
| Date of Event | 2019-01-10 |
| Date Mfgr Received | 2019-02-14 |
| Date Added to Maude | 2019-02-06 |
| 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. 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 | FLEX-CATCH 4 WIRE NITINOL BASKET |
| Generic Name | EXTRACTOR, STONE REMOVAL |
| Product Code | FGO |
| Date Received | 2019-02-06 |
| Model Number | NT4F19115 |
| Lot Number | 91802433 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 ROAD SOUTHBOROUGH MA 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-06 |