LIGHTSTRIKE ROBOT
Report
- Report Number
- 3014531752-2022-00001
- Event Type
- Malfunction
- Date Received
- December 20, 2022
- Date of Event
- August 22, 2022
- Report Date
- January 4, 2023
- Manufacturer
- XENEX DISINFECTION SERVICES INC.
- Product Code
- MKB
- PMA / PMN Number
- N/A#S-P#N/A
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- 003
Narratives
THE INVESTIGATION IS ONGOING AT THIS TIME. THERE IS NOT ENOUGH EVIDENCE TO INDICATE THAT IF THIS EVENT WERE TO REOCCUR THAT IT WOULD LIKELY LEAD TO SERIOUS INJURY. THROUGH HAZARD ANALYSIS, IT HAS BEEN DETERMINED THAT THERE WOULD HAVE TO BE ADDITIONAL ENVIRONMENTAL CONDITIONS (E.G. THE PRESENCE OF FLAMMABLE OR COMBUSTIBLE SUBSTANCES), TO LEAD TO SERIOUS INJURY. XENEX DECIDED TO REPORT THIS PRODUCT PROBLEM TO FDA OUT OF AN ABUNDANCE OF CAUTION WHILE OUR INVESTIGATION CONTINUES.
ON 12/02/2022, THE XENEX TECH SUPPORT TEAM OPENED CASE (B)(4) WHERE CUSTOMER DEVICE A000285 WAS REPORTED TO HAVE A DAMAGED POWER CORD SOCKET AND A MELTED POWER CORD PLUG. NO ADVERSE EVENTS WERE REPORTED BY THE CUSTOMER FACILITY. XENEX REQUESTED FOR DEVICE A000285 TO BE RETURNED FOR INVESTIGATION. BECAUSE OF THE SIMILARITIES TO THE EVENT DESCRIBED IN (B)(4) (DEVICE A000132) WHICH WAS SENT TO FDA ON 09/21/2022, XENEX IS SUBMITTING THIS FOLLOW-UP REPORT. THE PURPOSE OF THIS FOLLOW-UP IS TO INDICATE HOW THE FINDINGS IN CASE (B)(4) RELATE TO, AND SUPPORT ROOT CAUSE DETERMINATION OF THE MALFUNCTION WHICH WAS THE SUBJECT OF THE ORIGINAL REPORT. DEVICE A000285 ARRIVED AT XENEX ON 12/22/2022 AND WAS INSPECTED BY THE ENGINEERING TEAM. THE DEVICE SHOWED NON-MANUFACTURER MODIFICATIONS TO THE PLUG-END OF THE POWER CORD WHICH RESULTED IN COMPLETELY SEVERED HOT LEAD WIRES, AND SOME SEVERED CONDUCTORS IN THE NEUTRAL AND GROUND WIRES. EXCESSIVE MECHANICAL STRAINING WAS FOUND AT 90-DEGREES OF THE SOCKET. LASTLY, ADHESIVE TAPE SIMILAR TO DUCT TAPE WAS WRAPPED AROUND THE POWER CORD PLUG WITH INDICATIONS THAT THE ADHESIVE HAD BEGUN TO FLOW AROUND THE POWER CORD PLUG AND APPLIANCE INLET CONTACTS. DESPITE THE SIMILARITIES OF THE TWO CASES, THE DAMAGE TO THE POWER CORD PLUG OF DEVICE A000285 WAS SUPERFICIAL, AND NOT TO THE DEGREE OF THAT OF A000132. BASED ON THE INVESTIGATION, THE ROOT CAUSE OF THE ISSUE IS BELIEVED TO BE THAT THE ROBOT-SIDE POWER CORD CONNECTION WAS PHYSICALLY LOOSE. THIS CAUSED THE STAFF AT THE HOSPITAL TO INTRODUCE AN UNAUTHORIZED FOREIGN SUBSTANCE TO MITIGATE THE ISSUE. THIS FOREIGN MATERIAL WAS NOT RATED FOR THE ENVIRONMENT IN WHICH IT WAS USED AND LED TO THE EVENT. XENEX WILL CONTINUE TO TAKE STEPS TO REPRODUCE THE INCIDENT IN ORDER TO DETERMINE WHETHER ADDITIONAL FAULT CONDITIONS MAY HAVE ALSO EXISTED AND CONTRIBUTED TO THE OVERALL EVENT. INVESTIGATION AND DETERMINATION OF POSSIBLE CORRECTIVE ACTIONS WILL CONTINUE AND ADDITIONAL INFORMATION WILL BE REPORTED IN SUPPLEMENTAL REPORTS. CORRECTIONS: THE FOLLOWING CORRECTIONS WERE DONE TO THE ORIGINAL REPORT: SECTION B4: DATE OF THIS REPORT. SECTION D2 : TYPE OF DEVICE/PRODUCT CODE. SECTION G6: TYPE OF REPORT. SECTION H2: IF FOLLOW-UP, WHAT TYPE? SECTION H10: ADDITIONAL NARRATIVE/DATA.
DEVICE A000132 WAS RUNNING A DISINFECTION CYCLE IN AN UNOCCUPIED ROOM. ROOM SMOKE DETECTOR WAS TRIGGERED. CUSTOMER ENTERED THE ROOM AND FOUND THE POWER CORD PARTIALLY MELTED AT DEVICE INTERFACE. NO ADVERSE EVENTS REPORTED.
DEVICE A000132 WAS RUNNING A DISINFECTION CYCLE IN AN UNOCCUPIED ROOM. ROOM SMOKE DETECTOR WAS TRIGGERED. CUSTOMER ENTERED THE ROOM AND FOUND THE POWER CORD PARTIALLY MELTED AT DEVICE INTERFACE. NO ADVERSE EVENTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2023600 | LIGHTSTRIKE ROBOT | UV DISINFECTANT | MKB | XENEX DISINFECTION SERVICES INC. | LSMUV6-FT | N/A | |
| 2837226 | LIGHTSTRIKE ROBOT | UV DISINFECTANT | MKB | XENEX DISINFECTION SERVICES INC. | LSMUV6-FT | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |