MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2017-10-19 for PENTAX FI-16RBS manufactured by Hoya Corporation Pentax Tokyo Office.
[90651972]
Hoya corporation pentax (b)(4) office, specification developer, (b)(4) importer, (b)(4) (importer) is submitting the report on behalf of hoya corporation pentax (b)(4). Product code is class 1, exempt from fda 510k.
Patient Sequence No: 1, Text Type: N, H10
[90651973]
Pentax medical (b)(6) became aware of a report for an event which occurred in france regarding contamination of pentax model fi-16rbs/serial (b)(4) before shipment of the device to the customer. Details of reprocessing and sampling of the device are as follows: prior to sampling the device, the device was manually cleaned twice with the detergent alkazyme and reprocessed in an aer wassenburg wd440 202 with wassenburg chemicals. Sampling performed on (b)(6) 2016 indicated >100 cfu of micrococcus sp and staphylococcus coag negative detected in the suction channel. After receiving the sampling results, the device was manually cleaned twice with the detergent alkazyme and reprocessed in aer wassenburg wd440 202 with wassenburg chemicals. The results of the second sampling performed on 10/jun/2016 confirmed the device conformed per french regulations. Pentax medical (b)(6) shipped the device to the customer on 20/jun/2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610877-2017-00415 |
| MDR Report Key | 6961110 |
| Report Source | FOREIGN |
| Date Received | 2017-10-19 |
| Date of Report | 2016-06-09 |
| Date Facility Aware | 2016-06-09 |
| Report Date | 2017-12-20 |
| Date Reported to FDA | 2017-12-20 |
| Date Reported to Mfgr | 2017-12-20 |
| Date Mfgr Received | 2016-06-09 |
| Device Manufacturer Date | 2016-04-21 |
| Date Added to Maude | 2017-10-19 |
| 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. MATTHEW VERNAK |
| Manufacturer Street | 3 PARAGON DRIVE |
| Manufacturer City | MONTVALE NJ 07645 |
| Manufacturer Country | US |
| Manufacturer Postal | 07645 |
| Manufacturer Phone | 2015712300 |
| 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 | 3 |
| Brand Name | PENTAX |
| Generic Name | FIBER INTUBATION SCOPE |
| Product Code | CAL |
| Date Received | 2017-10-19 |
| Model Number | FI-16RBS |
| Device Availability | N |
| Device Age | 2 MO |
| 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 | 2017-10-19 |