LUMENIS BE INC.
Report
- Report Number
- 3020611964-2022-00004
- Event Type
- Malfunction
- Date Received
- November 30, 2022
- Date of Event
- October 30, 2022
- Report Date
- November 30, 2022
- Manufacturer
- LUMENIS BE INC
- Product Code
- HLJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
ON 10/31/2022 LUMENIS BE RECEIVED NOTIFICATION THAT THE (B)(6) HAD AN EVENT WHERE THE SPARE BATTERY ON THE LIO CHARGER BLEW UP AND LAUNCHED ITSELF ACROSS UNOCCUPIED TREATMENT ROOM OVER THE WEEKEND OF (B)(6) 2022. NO ONE WAS INVOLVED IN THE INCIDENT AND THERE WERE NO INJURIES. THE UNIT WAS THE SMART LIO AC-1076020_SN: (B)(4). A SERVICE ENGINEER WAS DISPATCHED TO THE CLINIC TO EVALUATE THE EVENT AND PHOTOS WERE OBTAINED OF THE BATTERY AND CHARGING UNIT AS WELL AS FLOOR TILE DAMAGE WHERE THE BATTERY LANDED AND BURNED UP. THE CE NOTES ARE AS FOLLOWS; "TURNED ON VISION ONE LASER AND CHECKED PHYSICAL DAMAGES AND NONE FOUND. CHECKED ENERGY ON BOTH THE SLIT LAMP AND LIO HEADSET. THE ENERGY IS IN LUMENIS SPECIFICATIONS, AND THE LASER IS READY FOR USE. THE SPARE BATTERY FOR THE LIO HEADSET SEEMS TO BE THE ISSUE AND/OR CHARGING STATION. MY CONTACT (B)(6) HAS PICTURES OF THE INCIDENT." CONTACT WITH THE OEM MANUFACTURER KEELER (IN THE UK) FINDS THAT THEY HAVE NOT SEEN ANYTHING LIKE THIS HAPPEN BEFORE (ALSO LUMENIS' EXPERIENCE - FIRST TIME AN EXPLOSION EVENT HAS BEEN SEEN) AND A REQUEST TO RETURN ALL COMPONENTS OF THE LIO ASSEMBLY WAS MADE. THE ASSEMBLY OF THE LIO UNIT AND CHARGING STATION WAS BOXED UP AND RETURNED TO KEELER FOR FAILURE ANALYSIS ON 11/11/2022. SUBSEQUENT INVESTIGATION BY KEELER FINDS THAT THEY WERE UNABLE TO DETERMINE THE ROOT CAUSE OF THE BATTERY FAILURE AND THUS HAVE FORWARDED THE REMNANTS OF THE BATTERY AND CHARGER TO ITS OWN MANUFACTURER FOR FURTHER ANALYSIS. THIS EVENT WAS REPORTED TO MHRA BY KEELER AS #(B)(4). A REVIEW OF THE LIO ASSEMBLY DHR (MODEL AC-1076020 SERIAL NUMBER (B)(4)) RECORDS SHOWED THAT THE SYSTEM WAS MANUFACTURED ACCORDING TO RELEVANT PROCEDURES, TESTED BEFORE RELEASE AND SHIPPED ACCORDING TO SPECIFICATIONS. THE SYSTEM PASSED ALL TESTING AND MET ALL LUMENIS SPECIFICATIONS PRIOR TO THE RELEASE FOR SALE. THE MANUFACTURE DATE WAS 6/29/2017 AND THE LIO WAS INSTALLED 11/01/2019. A REVIEW OF THE PURCHASE DATA FINDS THAT (B)(4) SLIMLINE LITHIUM-ION BATTERIES HAVE BEEN SOLD SINCE JUNE 2017. AS THERE WAS NO ONE INVOLVED IN THIS INCIDENT (PATIENT OR PRACTITIONER) THUS NO INJURIES, THERE WAS NO INCIDENT FORM RECEIVED AND NO CLINICAL INVESTIGATION REQUIRED. A REVIEW OF THE KEELER CERTIFICATION TESTING DOCUMENTS FOR THE LIO ASSEMBLY (REPORT (B)(4)) FINDS IT WAS CONDUCTED TO IEC 62133:2012, SAFETY TESTING FOR THE LITHIUM ION BATTERY FROM A NATIONALLY RECOGNIZED TESTING LABORATORY (NRTL) - TUV RHINELAND. A NUMBER OF TESTS WERE CONDUCTED AND THE RESULTS DOCUMENTED. SOME OF THE TESTING THAT IS PERTINENT TO THIS CASE ARE THE "THERMAL ABUSE" AND "OVER-CHARGING OF BATTERY" TESTS. IN EACH TEST, THEY WERE LOOKING FOR "FIRE OR EXPLOSION" AS A RESULT - WHICH THEY DIDN'T SEE DURING THE TESTING. THE THERMAL OR OVER-CHARGING TESTING THAT WAS DONE WAS FOR 20 OR 30 MINUTES AT A TIME. THERE WAS NO INFORMATION ABOUT BATTERY OR CHARGER EXPECTED LIFE. SUBSEQUENT CONVERSATION WITH KEELER FINDS A 5-YEAR LIFE EXPECTANCY FOR THE BATTERY. A LUMENIS SCAR (#2022-11-01) WAS ISSUED TO KEELER ON 11/2/2022 TO ADDRESS THIS ISSUE AND CONTAIN ALL THE FINDINGS AND CORRECTIVE ACTIONS. A REVIEW OF THE KEELER LIO RISK ASSESSMENT DOCUMENT PR31 FINDS SEVERAL REFERENCES TO BATTERY FAULT CONDITIONS LEADING TO OVERHEATING AND POSSIBLE THERMAL BURNS BUT NO REFERENCE TO EXPLOSION DUE TO OVERHEATING. AS SUCH, A REQUEST WAS MADE TO KEELER TO CONDUCT A HEALTH HAZARD EVALUATION TO SPECIFICALLY ADDRESS THE POSSIBILITY OF A FIRE CAUSED BY OVERHEATING AND EXPLOSION OF THE LITHIUM IN THE BATTERY. THE RISK ASSESSMENT RETURNED TO LUMENIS FOR THIS EVENT REPORTS THE FOLLOWING; SEE RISK LINE B 18 IN THE 5-3 PR31 RISK ASSESSMENT TABLE LIO, REFER TO TESTING REPORTS IN SUPPORTIVE DOCUMENT (REFERENCED BELOW). RISK LINE B 18 SHOWS MAJOR USER BURN RELATED TO BATTERY FAULT (POST MITIGATION) AS PROBABILITY=1, SEVERITY=3 WITH A RISK LEVEL OF LOW. (B)(6) SLIMLINE LITHIUM-ION BATTERIES HAVE BEEN SOLD SINCE JUNE 2017, THIS IS AN ISOLATED INCIDENT WITH FAILURE RATE OF 0.001%. EP59-30785-ART-F - ENGLISH IFU; SECTION 6 PROVIDES GUIDANCE ON BATTERY CHARGER USAGE. THE SLIMLINE LITHIUM-ION BATTERY HAS A SAFETY CIRCUIT TO SIGNIFICANTLY REDUCE OVER CHARGING / DISCHARGING. CASES AROUND THE BATTERY CELLS ARE HB RATED (UL94) ABS, CREATING A FIRE-RETARDANT BARRIER. CONCLUSION; THERE IS AN INSIGNIFICANT RISK TO USERS OF THE SLIMLINE LITHIUM-ION BATTERIES OF OVERHEATING/ 'EXPLODING' IN THE MARKET BASED ON THE FAILURE OF 0.001% AND THE COMPREHENSIVE TESTING CONDUCTED. NO FURTHER ACTIONS REQUIRED; WE WILL CONTINUE TO MONITOR ANY INCIDENTS VIA THE QMS. LUMENIS WILL UPDATE ITS RISK FILE TO REFLECT THIS EVENT HAZARD AND WILL INCLUDE CONCLUSIONS OF KEELER HHE. PER THE DECISION TREE DETERMINATION, LUMENIS WILL REPORT THIS EVENT TO THE FDA IN AN ABUNDANCE OF CAUTION AS MDR #3020611964-2022-00004. LUMENIS WILL CONTINUE TO MONITOR THE EVENT AND AS ADDITIONAL INFORMATION BECOMES AVAILABLE, THE COMPLAINT RECORD WILL BE UPDATED ACCORDINGLY AND A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. LUMENIS WILL CLOSE THIS COMPLAINT AT THIS TIME. COMPLAINT TRENDING WILL CONTINUE TO MONITOR PER GLOBAL COMPLAINT HANDLING SOP (DOC NO. (B)(4)) AND PER POST MARKETING SURVEILLANCE PROCEDURE (DOC NO. (B)(4)).
SPARE BATTERY ON LIO CHARGER BLEW UP AND LAUNCHED ITSELF ACROSS UNOCCUPIED TREATMENT ROOM OVER THE WEEKEND OF (B)(6) 2022.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2330832 | LUMENIS BE INC. | LASER INDIRECT OPHTHALMOSCOPE | HLJ | LUMENIS BE INC | AC-1076020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |