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

Model Number EG36-J10UR

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/12/2021

Event Type  malfunction  

Manufacturer Narrative

This device is classified as import for export, therefore 510k is not applicable.Model eg36-j10ur-us is available in the usa with a 510k number k200090.We checked the returned unit and confirmed that the ccd module defective.Based on the result, we concluded that it was caused due to the excessive force applied on the ccd module.In addition, we confirmed that the u/d & r/l pulley wire ruptured; however, they are not the main cause, and/or irrelevant to the alleged complaint.Based on the technical report and/or the risk analysis results, it was evaluated to submit mdr.

Event Description

The time of event is unknown.There was no report of patient harm.Video image failure.

• Brand Name: PENTAX
• Type of Device: DIGITAL RADIAL 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 goeller ; 3 paragon drive; montvale, NJ 07645
• MDR Report Key: 12841878
• MDR Text Key: 284716459
• Report Number: 9610877-2021-50460
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04961333239535
• UDI-Public: 04961333239535
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EG36-J10UR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1