MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2015-08-19 for RUSCH MRI COND FIBER OPTIC LARYN KIT 005852300 manufactured by Teleflex Medical.
[23527056]
(b)(4). Upon receipt the gold pipe light and bulb base were detached from the blade. No obvious damage noted visually. The gold pipe light was re-installed onto the blade with no fitting or alignment issues noted. The blade was attached to a known good handle and fitting/alignment was not an issue. It was noted that the light was not burning after the blade was engaged. After further investigation it was determined the small incandescent bulb was burned out. The original complaint of the pipe light not fitting onto the blade cannot be confirmed. The complaint cannot be confirmed. Root cause cannot be established. No corrective/preventative actions will be assigned. No further action required.
Patient Sequence No: 1, Text Type: N, H10
[23527057]
The customer alleges having difficulty reassembling the gold pipe light onto the blade. The patient's condition is reported as fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1044475-2015-00311 |
| MDR Report Key | 5015166 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2015-08-19 |
| Date of Report | 2015-07-30 |
| Date of Event | 2015-07-29 |
| Date Mfgr Received | 2015-07-30 |
| Date Added to Maude | 2015-08-19 |
| 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 | MARGIE BURTON, RN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334965 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | 2917 WECK DRIVE |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RUSCH MRI COND FIBER OPTIC LARYN KIT |
| Generic Name | LARYNGOSCOPE KIT |
| Product Code | OGH |
| Date Received | 2015-08-19 |
| Returned To Mfg | 2015-08-11 |
| Catalog Number | 005852300 |
| Lot Number | UNKNOWN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-19 |