MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-06 for SINGLE FIBER OPTIC CABLE, 10FT, PINK FC1SP manufactured by Invuity, Inc.
[116559055]
During evaluation, it was noted that broken fibers were present throughout the cable. Additionally, the cable exhibited a concentrated number of broken fibers which indicates mishandling of the cable. The concentration of broken fibers led to an elevated temperature. Invuity's ifu clearly states to handle the cables with care and not to coil the cables tighter than six (6) inches.
Patient Sequence No: 1, Text Type: N, H10
[116559056]
During a hip replacement procedure, it was observed that the drape had a burn mark where the fiber optic cable had been resting upon it. There was no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011394215-2018-00005 |
| MDR Report Key | 7755286 |
| Date Received | 2018-08-06 |
| Date of Report | 2018-07-11 |
| Date of Event | 2018-07-11 |
| Date Mfgr Received | 2018-07-11 |
| Date Added to Maude | 2018-08-06 |
| 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 | MR JOHN KANG |
| Manufacturer Street | 444 DE HARO ST |
| Manufacturer City | SAN FRANCISCO CA 94107 |
| Manufacturer Country | US |
| Manufacturer Postal | 94107 |
| Manufacturer Phone | 4156552160 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SINGLE FIBER OPTIC CABLE, 10FT, PINK |
| Generic Name | SINGLE FIBER OPTIC CABLE, 10FT, PINK |
| Product Code | FST |
| Date Received | 2018-08-06 |
| Returned To Mfg | 2018-07-18 |
| Model Number | FC1SP |
| Catalog Number | FC1SP |
| Lot Number | UNKNOWN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVUITY, INC |
| Manufacturer Address | 444 DE HARO ST SAN FRANCISCO CA 94107 US 94107 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-06 |