MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-10 for PENTAX VNL-1570STK manufactured by Hoya Corporation Pentax Tokyo Office.
[178958930]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[178958931]
The reported complaint was called into pentax medical customer service on 12-dec-2019, and reported biofilm and corrosion found during pre-inspectional check of the endoscope and was documented as "potential endoscope contamination" involving a pentax medical video naso-pharyngo-laryngoscope(npl). No serious injury or death of a patient or user, or delay in the procedure which would require medical intervention was reported. The customer owned video naso-pharyngo-laryngoscope(npl) was received by pentax medical for evaluation on 19-dec-2019. The npl was inspected by pentax medical service on 27-dec-2019, and the following inspection findings were documented: segment crushed, passed dry leak test, short umbilical cable buckle at umbilical connector side, passed wet leak test, pve electrical connector frame mild corrosion. Pentax medical video naso-pharyngo-laryngoscope(npl), vnl-1570stk, serial number (b)(4), has been routinely serviced at a pentax facility since the device was put into service on 30-apr-2009. The duodenoscope underwent repairs including the following components: insertion flex tube w/seg pb-free, distal end assy with tube, bending rubber, biopsy inlet t-piece, biopsy inlet barrel, o-rings and seals, insertion/s-nipple attaching screw, o-ring(1. 25x3. 5), suction connection tube, o-ring(1. 2x3. 5). The naso-pharyngo-laryngoscope is pending repair completion, resampling and final qc approval as of 10-jan-2020.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610877-2020-00016 |
| MDR Report Key | 9576942 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-10 |
| Date of Report | 2019-12-12 |
| Date Mfgr Received | 2019-12-12 |
| Date Added to Maude | 2020-01-10 |
| 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, 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 | VIDEO NASO-PHARYNGO-LARYNGOSCOPE |
| Product Code | EQN |
| Date Received | 2020-01-10 |
| Returned To Mfg | 2019-12-19 |
| Model Number | VNL-1570STK |
| 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, 196-0012 JA 196-0012 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-10 |