MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2007-04-17 for NOVUS OMNI Z2133A3 R621-687-01 manufactured by Lumenis, Inc..
[3000388]
This complaint concerns an apparent flashback to the physician during a retinal procedure with the novus omni and the fiber delivery device. This customer's novus omni device is installed with two binocular viewing ports. Per the initial reporter, the customer was aware that one of their two binocular viewing ports had a defective eye safety filter (esf) at the time of the procedure in question, and the customer used the device anyway. The customer's clinical engineering was called to check the set-up. Customer's clinical engineering said the physician would be protected by the esf, but that the scrub tech, who planned to watch at an observation port, would not. Based on the analysis by the customer clinical engineering, the scrub tech wore laser goggles. When the physician operated the laser, actually the scrub tech was protected by the esf, and the physician was not protected by the esf; this situation led to the physician receiving an apparent flashback. Per the initial reporter, the physician had no symptoms, but planned to have his eyes checked after completing his cases for the day. Lumenis requested add'l details regarding status of the physician after the incident and medical intervention, if any. These details were not provided by the customer. Per the initial reporter, at the time of the incident, the programmed setting was 500 mw. The exposure was 2 seconds in duration per the user facility mdr. Add'l info from u/f report: (b)(4): during eye surgery, using coherent (lumenis) laser - filter did not function when fired and surgeon (not pt) received indirect 2 second 500 mw reflection.
Patient Sequence No: 1, Text Type: D, B5
[10295963]
Device eval and root cause: the lumenis ce verified that the esf at the physician binocular viewing port was defective. Inadequate eye protection was used. Customer knew one esf had malfunction and used the device anyway. Results: customer attempted to mitigate the esf problem by having their clinical engineering check which esf had failed and make recommendations. However, the customer clinical engineer analysis and/or its implementation by the operating room staff resulted essentially. In an installation error or wrong device configuration as the functional esf was paired with the protective glasses (double protection) and the inoperative esf was not paired with the protective glasses (no protection). The customer has previously used a third party provider to service this novus omni. It is not possible to determine whether the service by the third party service provider contributed in any way to the incident. The novus omni operator manual states: troubleshooting guide: should a major malfunction occur, a coherent (lumenis) service rep must be contacted. The eye filter message will also illuminate of the eye filter is improperly connected or if the filter is not operating properly. Caution: use of controls or adjustments or performance of procedures other than those specified here in may result in hazardous laser radiation exposure. The customer ordered and received a new eye safety filter esf. The lumenis hooked up both esfs and system operation normal. System ready for use. System passed operational and safety checks. Based on the initial details, the incident was determined not to be mdr reportable. (b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1720381-2007-00001 |
| MDR Report Key | 2838430 |
| Report Source | 99 |
| Date Received | 2007-04-17 |
| Date of Report | 2007-04-17 |
| Date of Event | 2007-03-07 |
| Report Date | 2007-03-15 |
| Date Reported to Mfgr | 2007-03-15 |
| Date Mfgr Received | 2007-03-07 |
| Device Manufacturer Date | 2003-04-12 |
| Date Added to Maude | 2012-11-23 |
| 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 | JANIS ARNGMI |
| Manufacturer Street | 5302 BETSY ROSS DR. |
| Manufacturer City | SANTA CLARA CA 95054 |
| Manufacturer Country | US |
| Manufacturer Postal | 95054 |
| Manufacturer Phone | 4087643208 |
| Manufacturer City | SALT LAKE CITY UT |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOVUS OMNI |
| Generic Name | ARGON PHOTOCOAGULATOR LASER |
| Product Code | HHR |
| Date Received | 2007-04-17 |
| Model Number | Z2133A3 |
| Catalog Number | R621-687-01 |
| ID Number | REG # 9093352 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LUMENIS, INC. |
| Manufacturer Address | 3959 WEST 1820 SOUTH SALT LAKE CITY UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-04-17 |