MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-14 for PENTAX FI-10BS manufactured by Hoya Corporation Pentax Tokyo Office.
[40590176]
(b)(4). Product code is class 1, therefore this device model is exempt from fda 510(k). This mdr was initiated as part of a capa-driven remediation effort related to filing of mdrs for complaints/events outside of the us (ous). As part of this remediation, pentax medical performed a retrospective mdr assessment of all ous events/complaints received since jan 2013. The retrospective assessment of this event prompted pentax medical to file this report.
Patient Sequence No: 1, Text Type: N, H10
[40590177]
Pentax medical was made aware of a report received by (b)(6) located in the (b)(6) stating "(b)(6) female patient with dental abscess requiring incision and drainage was listed on the emergency list, patient required awake fibreoptic intubation nasally because of sever trismus and limited mouth opening, awake fibreoptic was performed very easily and once the scope was in trachea, size 6. 0 nasal ett was passed over the scope into the trachea, on attempting to remove the scope from the tube, it was jammed together and after repeated attempt the scope came out, but the black rubber top piece became detached and stayed inside the top of the ett tube, this was held by another anaesthetist and withdrawn with the scope, and patient connected to the anaesthetic machine and ventilated with no problems," involving pentax model fi-10bs/serial (b)(4). The device involved in the event was returned to pentax (b)(4) for evaluation. Pentax (b)(4) performed an investigation and concluded the following: "the investigation of the affected device (pentax fi-10bs bronchoscope) was carried out immediately and revealed the following: the so called "insertion flexible tube" of the pentax fi-10bs bronchoscope was crushed. The integrity and the functionality of the device was severely impacted. This finally led to the endoscope being blocked in the endo tracheal tube that was used in combination with our device. Such crush / damage can definitely not happen during any procedure carried out at a patient. From what we have seen this crush must have occurred already some time ago, maybe during previous reprocessing or storage prior to this procedure. As per our ifu [ ]. The user must perform an inspection prior to use in order to make sure the device is in proper condition and fully operational. Any damage like this crush would be clearly identifiable if such inspection would have been carried out as required. According to the repair history the device has received regular maintenance. The last repair was carried out on (b)(6) 2013 at our workshop. We have identified a user error as root cause for this event. We like to emphasise that the device was not in operational condition prior to use. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610877-2016-00064 |
| MDR Report Key | 5499812 |
| Date Received | 2016-03-14 |
| Date of Report | 2013-06-04 |
| Date of Event | 2013-06-01 |
| Date Facility Aware | 2013-06-04 |
| Report Date | 2017-07-26 |
| Date Reported to FDA | 2017-07-26 |
| Date Reported to Mfgr | 2017-07-26 |
| Date Mfgr Received | 2013-06-04 |
| Device Manufacturer Date | 2003-01-07 |
| Date Added to Maude | 2016-03-14 |
| 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 | 0 |
| Brand Name | PENTAX |
| Generic Name | FIBER INTUBATION SCOPE |
| Product Code | CAL |
| Date Received | 2016-03-14 |
| Returned To Mfg | 2013-06-27 |
| Model Number | FI-10BS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 10 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 | 2016-03-14 |