MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-01-24 for BALLOON MAJ-1351 manufactured by Olympus Medical Systems Corp..
[134065123]
The subject device was not returned to olympus medical systems corp. (omsc) for evaluation. Therefore, the exact cause of the reported event could not be conclusively determined. The manufacturing record was reviewed and found no irregularities. This type of the event is most likely related to the operator's technique. Based on the past similar cases, it was known that the event occurred due to the following causes. The user could not attach the balloon to ultrasonic bronchoscope correctly. The instruction manual of bronchoscope describes a method "attaching the balloon".
Patient Sequence No: 1, Text Type: N, H10
[134065124]
During an unspecified procedure, the subject device was used. In the procedure, when the ultrasonic bronchoscope was pulled out from the patient's body, the subject device was missing from the tip of the bronchoscope. The intended procedure was completed with another device. Doctor did not know whether the device was fell into the patient body or outside the patient body. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2019-00949 |
| MDR Report Key | 8276606 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-24 |
| Date of Report | 2019-03-07 |
| Date of Event | 2018-12-27 |
| Date Mfgr Received | 2019-02-20 |
| Date Added to Maude | 2019-01-24 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR KAZUTAKA MATSUMOTO |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO-TO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal | 192-8507 |
| Manufacturer Phone | 426425177 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BALLOON |
| Generic Name | BALLOON |
| Product Code | PSV |
| Date Received | 2019-01-24 |
| Model Number | MAJ-1351 |
| Lot Number | 89K |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-01-24 |