INTUBRITE
Report
- Report Number
- 3000219639-2024-00117
- Event Type
- Malfunction
- Date Received
- November 15, 2024
- Date of Event
- October 10, 2024
- Report Date
- January 17, 2025
- Manufacturer
- SALTER LABS
- Product Code
- CCW
- PMA / PMN Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
H6: 4756 (APPROPRIATE IMPACT TERM/CODE NOT AVAILABLE): LARYNGOSCOPE. THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 15 NOV 2024 HAS BEEN INCLUDED IN THE HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUNMED HOLDINGS LLC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO SUNMED HOLDINGS LLC. SUNMED HOLDINGS LLC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE SUNMED HOLDINGS COMPLAINT DATABASE AND IS IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21 CFR 803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A SUNMED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSES SERIOUS INJURY. THE COMPLAINT OF "DIFFICULTY WITH INTUBATION" REGARDING AN UNKNOWN INTUBRITE LARYNGOSCOPE WAS NOT CONFIRMED. THE ROOT CAUSE COULD POSSIBLY BE A RESULT OF A DESIGN CHANGE. A RISK ASSESSMENT WAS PERFORMED, AND THE ULTIMATE RISK WAS DETERMINED TO BE LOW WHICH DOES NOT REQUIRE REPORTING TO THE CAPA REVIEW BOARD. THERE HAVE BEEN 23 OTHER COMPLAINTS REGARDING THE SAME PART FAMILY AND A SIMILAR ISSUE WITHIN THE 24 MONTHS PRECEDING THE REPORTING OF THIS ISSUE. A RESOLUTION LETTER WAS SENT TO THE CUSTOMER. COMPLAINTS WILL CONTINUE TO BE MONITORED FOR POSSIBLE TRENDS.
H6: 4756 (APPROPRIATE IMPACT TERM/CODE NOT AVAILABLE): LARYNGOSCOPE. THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 15 NOV 2024, HAS BEEN INCLUDED IN THE HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUNMED HOLDINGS LLC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO SUNMED HOLDINGS LLC. SUNMED HOLDINGS LLC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED, BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY, WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE SUNMED HOLDINGS COMPLAINT DATABASE. AND IS IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21 CFR 803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A SUNMED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSES SERIOUS INJURY.
THE LIGHT WAS TOO BRIGHT AND BLADE TOO THIN.
THE LIGHT WAS TOO BRIGHT AND BLADE TOO THIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 73822 | INTUBRITE | UNKNOWN INTUBRITE LARYNGOSCOPE | CCW | SALTER LABS | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |