MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-25 for PENTAX EPK-I5010 manufactured by Hoya Corporation Pentax Tokyo Office.
[129437220]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[129437221]
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 "sparking inside when scope plugged in" during the pre-inspection check. In a follow-up correspondence received from the pentex medical sales rep on (b)(6) 2018, sparking was heard from the vented lamp area and lamp was failing to illuminate properly. Also exposure control and mode would not switch to auto/average when scope was plugged in. The sparking was likely related to either the lamp or the igniter for the lamp in the processor. Lamp had less than 300 hours on it and was last replaced by customer. Sparking sound was brief and no smoke accompanied it. Scope was not sent for service as the problem is definitely processor related. Customer did try other scope model/serial but had no effect on the problem. Processor was sent in for service to pentax. On (b)(6) 2018, the user confirmed the above statements, also that the replacement bulbs were pentax medical lamps and that there was no user injury. The video processor was received and evaluated on (b)(6) 2018 by the pentax medical service department. The findings include that the lamp is not igniting and the customer complaint was confirmed. They also documented the scope c. Or handle screws are loose and that the customer last replaced the lamp on (b)(6) 2018, but the lamp was incorrectly installed. The heatsink cartridge is loose and the two long attaching screws are not properly screwed or attached to the lamp housing terminal resulting in the area where the sparking or arching sound is occurring. The incorrect installation also prevented the lamp to ignite and goes to auxiliary light instead. Lastly, there was a heavy ball of dust which blocks some portion of light and cooling air to circulate internally. No parts needed for repair. . The video processor was repaired and returned to the customer on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610877-2018-00532 |
| MDR Report Key | 8100588 |
| Date Received | 2018-11-25 |
| Date of Report | 2018-10-26 |
| Date Facility Aware | 2018-10-30 |
| Report Date | 2018-11-25 |
| Date Reported to FDA | 2018-11-25 |
| Date Reported to Mfgr | 2018-11-25 |
| Date Mfgr Received | 2018-10-30 |
| Date Added to Maude | 2018-11-25 |
| 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 | 0 |
| Brand Name | PENTAX |
| Generic Name | VIDEO PROCESSOR |
| Product Code | PEA |
| Date Received | 2018-11-25 |
| Returned To Mfg | 2018-11-01 |
| 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 | 2018-11-25 |