MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2017-07-07 for PENTAX FI-10RBS manufactured by Hoya Corporation Pentax Tokyo Office.
[79349899]
(b)(4). Product code is class 1, exempt from fda 510k.
Patient Sequence No: 1, Text Type: N, H10
[79349900]
Pentax medical became aware of a report for an event which occurred in (b)(6) stating during a bronchial examination, pentax model fi-10rbsd/serial (b)(4) was being used in combination with portex blue line tracheal tube (37fr) manufactured by (b)(4), and as the physician withdrew the non-rigid laryngoscope from the tracheal tube, black resin stripped off the non-rigid laryngoscope and fell into the patient. A pentax representative visited the facility on (b)(6) 2017 and confirmed the damaged section on the non-rigid laryngoscope was about 10cm from the distal end in which the black resin was stripped off. Information from the nurse chief officer, confirmed from the physician, stated after inserting, there was resistance when withdrawing the non-rigid laryngoscope. The debris which fell into the patient was removed by using another endoscope (bronchoscope). After removing the debris, an x-ray was performed on the patient which confirmed no debris remained. The physician explained the incident to the patient, who accepted the explanation. Furthermore, the facility stated xylocaine (lidocaine) spray was used as a lubricant. The facility also stated a leak test was performed and no outer damage was observed on the non-rigid laryngoscope before use. The non-rigid laryngoscope is manually cleaned and sterilized by eog after each use. In addition, during the visit on (b)(6) 2017, the pentax representative removed the non-rigid laryngoscope from the facility and returned it to pentax (b)(4) for evaluation. Based on the evaluation and the investigation performed by pentax (b)(4), it was concluded the deterioration of the insertion tube surface was due to the lidocaine and eo sterilization use at the facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610877-2017-00402 |
| MDR Report Key | 6694543 |
| Report Source | FOREIGN |
| Date Received | 2017-07-07 |
| Date of Report | 2017-06-07 |
| Date of Event | 2017-06-07 |
| Date Facility Aware | 2017-06-07 |
| Report Date | 2017-07-07 |
| Date Reported to FDA | 2017-07-07 |
| Date Reported to Mfgr | 2017-07-07 |
| Date Mfgr Received | 2017-06-07 |
| Date Added to Maude | 2017-07-07 |
| 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 | 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 | 2017-07-07 |
| Returned To Mfg | 2017-06-08 |
| Model Number | FI-10RBS |
| Operator | PHYSICIAN |
| 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 | 1. Required No Informationntervention | 2017-07-07 |