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

Model Number EC38-I10CF

Device Problem Obstruction of Flow (2423)

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

Event Date 03/21/2024

Event Type  malfunction  

Event Description

The time of event is unknown.There was no report of patient harm.Air/water tube clogged.

Manufacturer Narrative

This device is not distributed in us so that 510k# is blank.The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the air tube clogged.Based on the result, we concluded that it was caused due to the inadequate/insufficient reprocessing at the facility on the air tube.In addition, our technician confirmed that the cmos module with drive pcb cloudy (not clear view), the air/water nozzle deformed, the root brace rubber (insertion flexible tube) cut, the aft suction tube dirty, and the cmos module with drive pcb objective lens cracked; however, these defects are not the main cause, and/or irrelevant to the alleged complaint.Based on the technical report ""hr-rpt-0630(air/water & jet water channels)"" and/or the risk analysis results, it was evaluated to submit mdr.

• Brand Name: PENTAX
• Type of Device: IMAGINA COLONOSCOPE
• 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: gurvinder nanda ; 3 paragon drive; montvale, NJ 07645 ; 2015712318
• MDR Report Key: 19001851
• MDR Text Key: 339059691
• Report Number: 9610877-2024-52610
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EC38-I10CF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2024
• Date Manufacturer Received: 03/21/2024
• 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