MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; RETROVIEW VIDEO COLONOSCOPE

Model Number EC-3490TFI

Device Problem Unintended Movement (3026)

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

Event Date 12/17/2021

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

This device is not distributed in us so that 510k# is blank.We checked the returned unit and confirmed the ccd module as 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 bending rubber leakage, the insertion flexible tube (ift) buckled, the root brace rubber cut, and the remote control buttons cut; 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.

• Brand Name: PENTAX
• Type of Device: RETROVIEW VIDEO COLONOSCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-10; akishima-shi; tokyo, 196-0 012; JA 196-0012
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-10; akishima-shi; tokyo, 196-0 012; JA 196-0012
• Manufacturer Contact: william ; 3 paragon drive; montvale; nj 07645
• MDR Report Key: 13091453
• MDR Text Key: 289069702
• Report Number: 9610877-2021-51008
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EC-3490TFI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2021
• Initial Date FDA Received: 12/28/2021
• 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