MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-05 for PENTAX manufactured by Hoya Corporation Pentax Tokyo Office.
[123065838]
(b)(4). Model and serial number not provided, therefore the pma/510(k) number is unknown. Ebus customer confirmed on 19sep2018 the ebus was not being returned as they do not feel it was a part of the incident. (b)(4). Method: device not returned. Result: no findings available. Conclusion: cause not established. Pentax medical endobronchial ultrasound(ebus) unknown model, unknown serial number is being reported under mdr 9610877-2018-00426. Pentax video bronchoscope, model eb-1570k, serial number (b)(4), used once the ebus was switched out is being submitted under mdr 9610877-2018-00427.
Patient Sequence No: 1, Text Type: N, H10
[123065839]
Pentax medical was made aware of a complaint on 06sep2018 of an event that occurred in the emea on 30aug2018. The procedure involved a pentax medical endobronchial ultrasound(ebus), unknown model and serial number, that was used for a transbronchial needle aspiration (tbna) at the 4r (lower right paratracheal lymph node stations). The patient was being tended for bleeding after the ebus was used. No malfunction was reported to have occurred with the ebus, however the ebus was switched to a pentax video bronchoscope, model eb-1570k, serial number (b)(4). The suction port on the video bronchoscope did not work properly and stopped working all together during the procedure which made controlling bleeding difficult. Additionally, the suction eventually got stuck in 'on' position and resulted in an accidental removal of a clot and could have resulted in further bleeding per the customer. Bleeding was controlled with iced saline and there was no reported significant harm to the patient. The ebus customer confirmed on 19sep2018 the ebus was a pentax (b)(4) (model/serial number not provided), however they did not send it for repair as they do not feel it was a part of the incident. No additional information regarding the ebus appears to be available. The reason for switching to the video bronchoscope was not provided. Pentax video bronchoscope, model eb-1570k, serial number (b)(4), used once the ebus was switched out is being submitted under mdr 9610877-2018-00427.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610877-2018-00426 |
| MDR Report Key | 7939190 |
| Date Received | 2018-10-05 |
| Date of Report | 2018-09-06 |
| Date of Event | 2018-08-30 |
| Date Facility Aware | 2018-09-06 |
| Report Date | 2018-10-05 |
| Date Reported to FDA | 2018-10-05 |
| Date Reported to Mfgr | 2018-10-05 |
| Date Mfgr Received | 2018-09-06 |
| Date Added to Maude | 2018-10-05 |
| 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. WILLIAM GOELLER (TEMPORARY) |
| Manufacturer Street | 3 PARAGON DRIVE |
| Manufacturer City | MONTVALE NJ 07645 |
| Manufacturer Country | US |
| Manufacturer Postal | 07645 |
| Manufacturer Phone | 8004315880 |
| Manufacturer G1 | HOYA CORPORATION PENTAX TOKYO OFFICE |
| Manufacturer Street | TSUTSUJIGAOKA 1-1-110 AKISHIMA-SHI |
| Manufacturer City | TOKYO, 196-0012 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 196-0012 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PENTAX |
| Generic Name | VIDEO ULTRASOUND BRONCHOSCOPE |
| Product Code | PSV |
| Date Received | 2018-10-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOYA CORPORATION PENTAX TOKYO OFFICE |
| Manufacturer Address | TSUTSUJIGAOKA 1-1-110 AKISHIMA-SHI TOKYO, 196-0012 JA 196-0012 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-05 |