MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-03 for PENTAX EG38-J10UT manufactured by Hoya Corporation Pentax Tokyo Office.
[188139529]
Pentax medical became aware of a report on 03-feb-2020 stating, "the axios stent did not come out in the axis because the erector did not open at 0 degrees - this caused friction on the wall of the esophagus, created a lesion with bleeding and obliged the physician to put clips to stop the bleeding. " involving digital linear ultrasound scope model eg38-j10ut/serial (b)(4). The customer reported using boston scientific axios system,, which is not listed as recommended for use within the instructions for use(ifu) of the eg38-j10ut compatibility section. The user facility used the endoscope on the patient without checking before use that the endoscope elevator could be "opened". Lastly, the user facility removed the endoscope from the patient without realizing that the tip of axios was sticking out of the elevator. As a result, the patient's esophageal wall was damaged by the tip of boston scientific axios product. The endoscope was not returned to pentax medical for evaluation and the user facility continues to use the endoscope.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518897-2020-00053 |
| MDR Report Key | 9782686 |
| Date Received | 2020-03-03 |
| Date of Report | 2020-02-03 |
| Date of Event | 2020-02-03 |
| Date Facility Aware | 2020-02-03 |
| Report Date | 2020-03-03 |
| Date Reported to FDA | 2020-03-03 |
| Date Reported to Mfgr | 2020-03-03 |
| Date Added to Maude | 2020-03-03 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PENTAX |
| Generic Name | DIGITAL LINEAR ULTRASOUND SCOPE |
| Product Code | ODG |
| Date Received | 2020-03-03 |
| Model Number | EG38-J10UT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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. Other | 2020-03-03 |