MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2017-08-11 for PENTAX FI-10RBS manufactured by Hoya Corporation Pentax Tokyo Office.
[82602004]
Three patients are mentioned in this mdr. The first patient indicated the presence of klebsiella pneumoniae at the time of the fibroscopy. The second patient underwent a fibroscopy with the same scope, after the first patient, and became infected with klebsiella pneumoniae. The third patient had a fibroscopy on (b)(6) 2017 with no reported adverse events. Mdr 9610877-2017-00406 is being submitted for the second patient involved in the cross contamination event. Mdr 9610877-2017-00407 is being submitted for the third patient who had a fibroscopy on (b)(6) 2017. (b)(4). Exempt = product code is class 1, exempt from fda 510(k).
Patient Sequence No: 1, Text Type: N, H10
[82602005]
On 07/12/17, pentax medical was made aware of a report from the (b)(6) regarding an event in (b)(6) of cross contamination of klebsiella pneumoniae via a fiberscope (fi-10rbs serial no. (b)(4)) between 2 patients in cardiothoracic intensive care on (b)(6) 2017. (b)(6) reported that the first patient indicated the presence of the bacteria at the time of the procedure and the second patient tested positive following the procedure. (b)(6) reported that the 2 patients died from their underlying pathologies. (b)(6) reported that a third patient who had a fibroscopy on (b)(6) 2017 (before the endoscope was quarantined) was informed of the possible exposure and has no clinical signs of infection. (b)(6) further reported that the endoscope was still contaminated despite disinfection. The fiberscope was received by pentax (b)(4) from the facility on (b)(6) 2017 without any information about the contamination. The inspection found a perforated bending rubber. The fiberscope was repaired and reprocessed. Microbiological sampling was performed on the fiberscope on (b)(6) 2017. The sampling laboratory reported the following results: operating channel 1 cfu of bacillus sp. , suction channel <1 cfu. A request for the device to be shipped from pentax (b)(4) to pentax europe (b)(4) was made on 07/13/2017. Pentax europe (b)(4) received the fiberscope ((b)(4)) on 07/17/2017. Inspection performed by pentax europe (b)(4) found the fiberscope to be leaky at the control body at the valve seat and appeared to have been previously repaired. In addition, the device looked worn, many scratches were noted and the insertion flexible tube was buckled and squeezed. Microbiological sampling was performed on the fiberscope on (b)(6) 2017. Results showed no critical pathogens, therefore the device met the hygienic microbiological requirements. A device history review was performed by the manufacturer which showed no discrepancies. The device is currently at pentax europe (b)(4). Pentax europe (b)(4) and pentax (b)(4) are currently investigating the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610877-2017-00406 |
| MDR Report Key | 6789915 |
| Report Source | FOREIGN |
| Date Received | 2017-08-11 |
| Date of Report | 2017-07-12 |
| Date of Event | 2017-06-07 |
| Date Facility Aware | 2017-07-12 |
| Report Date | 2017-08-11 |
| Date Reported to FDA | 2017-08-11 |
| Date Reported to Mfgr | 2017-08-11 |
| Date Mfgr Received | 2017-07-12 |
| Device Manufacturer Date | 2014-08-05 |
| Date Added to Maude | 2017-08-11 |
| 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 | NON-RIGID LARYNGOSCOPE |
| Product Code | CAL |
| Date Received | 2017-08-11 |
| Returned To Mfg | 2017-07-03 |
| Model Number | FI-10RBS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 3 YR |
| 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 | 1. Death | 2017-08-11 |