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 2018-03-28 for MAJ-1351 (D) BALLOON manufactured by Olympus Medical Systems Corp..
[104045034]
The device was not returned to olympus for evaluation and limited information was provided by the user facility regarding the reported event. Therefore, the cause of the reported event could not be determined. If additional information becomes available, this report will be supplemented accordingly. Please cross reference mfr# 2951238-2018-00198.
Patient Sequence No: 1, Text Type: N, H10
[104045035]
Olympus was informed that the device fell off the distal tip of the bronchoscope and into the patient during a bronchoscopy procedure. The physician was able to retrieve the balloon from the patient. There was no patient harm/injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00220 |
| MDR Report Key | 7379853 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-03-28 |
| Date of Report | 2018-04-18 |
| Date of Event | 2018-02-27 |
| Date Mfgr Received | 2018-03-31 |
| Date Added to Maude | 2018-03-28 |
| 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 | MAJ-1351 (D) BALLOON |
| Generic Name | BALLOON |
| Product Code | PSV |
| Date Received | 2018-03-28 |
| Model Number | MAJ-1351 |
| Catalog Number | MAJ-1351 |
| Lot Number | UNKNOWN |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-28 |