MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2017-04-28 for PENTAX FI-16RBS manufactured by Hoya Corporation Pentax Tokyo Office.
[74106329]
(b)(4). Pma510(k): this product is exempt status.
Patient Sequence No: 1, Text Type: N, H10
[74106330]
Pentax medical became aware of a report for an event which occurred in (b)(6) regarding contamination of pentax model fi-16rbs/serial (b)(4). The report indicated that the endoscope was contaminated with >100 cfu candida parapsilosis after a double disinfection and sampling. The device was reprocessed and a second sampling was performed which detected 1 cfu. The second sampling result was considered satisfactory per the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610877-2017-00024 |
| MDR Report Key | 6531091 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2017-04-28 |
| Date of Report | 2017-03-30 |
| Date Facility Aware | 2017-03-30 |
| Report Date | 2017-04-28 |
| Date Reported to FDA | 2017-04-28 |
| Date Reported to Mfgr | 2017-04-28 |
| Date Mfgr Received | 2017-03-30 |
| Date Added to Maude | 2017-04-28 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KRISHNA GOVINDARAJAN |
| 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 | 3 |
| Brand Name | PENTAX |
| Generic Name | FIBER INTUBATION, SCOPE |
| Product Code | CAL |
| Date Received | 2017-04-28 |
| Model Number | FI-16RBS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| 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 | 2017-04-28 |