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 2017-07-24 for 0.035" SUREGLIDE STIFF, BX/5 41BX manufactured by Lake Region Manufacturing.
[80811690]
The device was not returned to olympus for evaluation. Olympus followed up with the user facility via telephone and in writing to obtain additional information regarding the reported event but with no result. The cause of the reported event cannot be determined at this time; however, the instruction manual warns users "inspect the device for any visible damage such as kinks, unwound coil, abrasion at the tip etc. "
Patient Sequence No: 1, Text Type: N, H10
[80811691]
Olympus was informed that during an unspecified procedure, the coating from the guidewire was peeling back and fell into the patient. It was reported that the surgeon manually removed the device fragments from the patient. The intended procedure was completed. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2017-00480 |
| MDR Report Key | 6736473 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-07-24 |
| Date of Report | 2017-09-15 |
| Date of Event | 2017-06-11 |
| Date Mfgr Received | 2017-08-31 |
| Date Added to Maude | 2017-07-24 |
| 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 | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 408935-512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 0.035" SUREGLIDE STIFF, BX/5 |
| Generic Name | 0.035" SUREGLIDE STIFF |
| Product Code | EYA |
| Date Received | 2017-07-24 |
| Returned To Mfg | 2017-08-21 |
| Model Number | 41BX |
| Catalog Number | 41BX |
| Lot Number | 10785233 |
| ID Number | UDI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LAKE REGION MANUFACTURING |
| Manufacturer Address | 340 LAKE HAZELTINE DRIVE CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-24 |