MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-30 for GREENLIGHT MOXY FIBER OPTIC 0010-2400 manufactured by Boston Scientific Corporation.
[185787443]
The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications. Analysis of the device revealed the glass cap has a circumferential fracture on the distal side of fiber/cap fusion zone at the bevel edge. The fiber proximal to fracture can rotate independently of outer flow tubing. The glass cap exhibits moderate devitrification at the output window and metal cap exhibits sever char. The fiber was tested with hene laser fixture, aim beam is present at fiber output window. There are no signs of breakage along length of fiber. The connector cone, segments and tabs appear in good condition and secured. The control knob is attached and aligned with fiber and can rotate the fiber. Due to the observed circumferential fracture at distal side, the potential for forward firing may exist. Based on the observed circumferential fracture at distal side finding, an evaluation conclusion code of design inadequate for purpose of the device was assigned to this investigation. A temperature higher or close to epoxy degradation temperature near the laser beam output window may be a major impacting factor leading to epoxy failure and subsequent fiber breakage. Tissue adhesion from constant and heavy tissue contact could be the major cause resulting in the observed circumferential fracture.
Patient Sequence No: 1, Text Type: N, H10
[185787444]
Analysis of the device found that the glass cap has a circumferential fracture on the distal side of fiber/cap fusion zone at the bevel edge. Based on device analysis, the potential for forward firing may exist. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937094-2020-00362 |
| MDR Report Key | 9901760 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-03-30 |
| Device Manufacturer Date | 2019-11-14 |
| Date Added to Maude | 2020-03-30 |
| 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 | ALYSON HARRIS |
| Manufacturer Street | 150 BAYTECH DRIVE |
| Manufacturer City | SAN JOSE CA 95134 |
| Manufacturer Country | US |
| Manufacturer Postal | 95134 |
| Manufacturer Phone | 4089353452 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | PMT 741 PERSIARAN CASSIA SELAT |
| Manufacturer City | BANDARCASSIA, PULAU PINAN 14110 |
| Manufacturer Country | MY |
| Manufacturer Postal Code | 14110 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GREENLIGHT MOXY FIBER OPTIC |
| Generic Name | POWERED LASER SURGICAL INSTRUMENT |
| Product Code | GEX |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2020-03-09 |
| Model Number | 0010-2400 |
| Catalog Number | 0010-2400 |
| Lot Number | 0024765852 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | PMT 741 PERSIARAN CASSIA SELAT BANDARCASSIA, PULAU PINAN MY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |