MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-08-05 for PENTAX FI-9RBS manufactured by Hoya Corporation Pentax Tokyo Office.
[51347635]
(b)(4). Product code for this device is class 1, therefore this device is exempt from fda 510k. The device involved in the event was not returned to pentax medical since the facility has since validated the cleanliness of the device and the device has tested negative for bacteria. This report is being submitted for the first patient involved in the event. The 9610877-2016-00156 is being submitted for the second patient involved in the event.
Patient Sequence No: 1, Text Type: N, H10
[51347636]
On 07/08/2016, pentax medical was made aware of a report in (b)(6) that a pentax sales representative received a call from a facility stating that pentax model fi-9rbs/serial (b)(4) was found to be contaminated with mycobacteria. The pentax sales representative then visited the facility, in which the doctor stated one patient was infected with the same mycobacteria. The pentax sales manager visited the facility on 07/11/2016 to obtain additional event details. The doctor at the facility stated that a patient was found infected with mycobacteria in (b)(6) 2015. In (b)(6) 2016, the patient was again found to be infected with the same mycobacteria. In (b)(6) 2016, another patient was found to be infected with the same mycobacteria. Due to this, the facility cultured a sample from pentax model fi-9rbs/serial (b)(4), which tested positive for the same mycobacteria. All patients from the same hospital ward were then examined and 7 patients were found to be infected with the same mycobacteria. The facility stated pentax model fi-9rbs/serial (b)(4) was not used on all patients who tested positive for mycobacteria, however the source of the infection might possibly be pentax model fi-9rbs/serial (b)(4). Additional information was received from pentax (b)(4) on (b)(6) 2016 confirming a total of 7 patients tested positive for mycobacteria at this facility. Two (2) out of these 7 patients who tested positive for mycobacteria underwent procedures with pentax model fi-9rbs/serial (b)(4). On 07/12/2016, two pentax sales representatives and two pentax customer service representatives visited the facility and explained the recommended cleaning and reprocessing methods to one doctor and two nurses. During the visit, it was determined that the facility was not following pentax instructions for use. For example, the facility was not using cleaning liquid. Instead, flowing water was used to clean the endoscope. In addition, brushing was performed but, cleaning liquid was not being flushed into the channel of the endoscope. A clear description on the facility's cleaning method used for cleaning the suction control valve and the rubber inlet seal was not obtained. The high level disinfectant (hld) used at the facility is disopa. The facility did not seem to have sufficient knowledge of the hld controls at the facility. Training on the recommended cleaning and reprocessing methods was completed, and pentax medical is planning on training the facility staff periodically. The device involved in the event was not returned to pentax medical since the facility has since validated the cleanliness of the device and the device has tested negative for bacteria.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610877-2016-00153 |
| MDR Report Key | 5851872 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-08-05 |
| Date of Report | 2016-07-08 |
| Date Facility Aware | 2016-07-08 |
| Report Date | 2017-12-14 |
| Date Reported to FDA | 2017-12-14 |
| Date Reported to Mfgr | 2017-12-14 |
| Date Mfgr Received | 2016-07-08 |
| Device Manufacturer Date | 2014-07-28 |
| Date Added to Maude | 2016-08-05 |
| 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. MATTHEW VERNAK |
| 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 | NON-RIGID LARYNGOSCOPE |
| Product Code | CAL |
| Date Received | 2016-08-05 |
| Model Number | FI-9RBS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-08-05 |