MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; DIGITAL LINEAR ULTRASOUND SCOPE

Model Number EG38-J10UT

Device Problem Component or Accessory Incompatibility (2897)

Patient Problem Laceration(s) of Esophagus (2398)

Event Date 02/03/2020

Event Type  Injury  

Manufacturer Narrative

This model is not sold in the usa, therefore udi number is not applicable.Device is import for export so 510(k) does not apply.(b)(4).

Event Description

Pentax medical became aware of a report on (b)(6) 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.

• Brand Name: PENTAX
• Type of Device: DIGITAL LINEAR ULTRASOUND SCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi; tokyo, 196-0 012; JA 196-0012
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi; tokyo, 196-0 012; JA 196-0012
• Manufacturer Contact: william (temporary) ; 3 paragon drive; montvale, nj ; 4315880231
• MDR Report Key: 9782683
• MDR Text Key: 192741023
• Report Number: 9610877-2020-00044
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: REFER TO H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EG38-J10UT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other