MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-01-10 for PENTAX EPK-I5010 manufactured by Hoya Corporation Pentax Tokyo Office.
[132805394]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[132805395]
On (b)(6) 2018, pentax medical received a customer report stating video processor model epk-i5010, serial number (b)(4) was involved in a malfunction event. The user reported "light issue goes blaring bright - intermittently. " the end user responded via email to a follow-up correspondence on (b)(6) 2018, and stated that the failure occurred during a procedure and the processor had to be swapped out and the procedure restarted requiring additional anesthesia. He also noted that there was not any risks to the patient or potential for cross contamination. The user also stated that this issue occurred several to many times over the past year to year and a half, although this is the first service documented by pentax medical since installation on (b)(6) 2015. The video processor was received and evaluated on 19-dec-2018 by the pentax medical service department. The findings include that the lamp power supply unit lamp is not igniting due to a bad lamp power unit, the lamp does not ignite and goes to auxilliary light instead, the limiter switch is not working properly, displaying intermittent lines on the image confirming the customer complaint. Additional findings: limit switch actuator plate(2) bent. Ball plunger damaged. Scope connector handle loose. Air socket tube leaking. They also documented the ball plunger is bad with grinding tension when locking the scope, loose screws on scope locking assembly, and there was dust and corrosion. The video processor was repaired and returned to the customer on (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610877-2019-00174 |
| MDR Report Key | 8233307 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-01-10 |
| Date of Report | 2018-12-10 |
| Date Facility Aware | 2018-12-10 |
| Report Date | 2019-01-09 |
| Date Reported to FDA | 2019-01-09 |
| Date Reported to Mfgr | 2019-01-09 |
| Date Mfgr Received | 2018-12-10 |
| Date Added to Maude | 2019-01-10 |
| 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. 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 |
| Manufacturer City | AKISHIMA-SHI, 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 | VIDEO PROCESSOR |
| Product Code | PEA |
| Date Received | 2019-01-10 |
| Returned To Mfg | 2018-12-19 |
| Model Number | EPK-I5010 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-01-10 |