MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; PENTAX MEDICAL VIDEO COLONOSCOPE EC38-I20C SERIES

Model Number EC38-I20CL

Device Problems Partial Blockage (1065); Poor Quality Image (1408)

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

Event Date 12/07/2023

Event Type  malfunction  

Event Description

Operation channel blocked, buckled.Spot in the image.This event occurred at the time of during inspection.There was no report of patient harm.This event meets the requirements for fda reportability; however, submission of this report does not constitute an admission that medical personnel, user facility, importer, manufacturer or product caused or contributed to the event.

Manufacturer Narrative

Pentax medical emea responded to the good faith effort request via email on 09-dec-2023 the following questions.Question: can you give us some specifics about what happened on site? for example, forceps for a procedure cannot be inserted, water cannot be flushed, etc.Answer: we only stated the problem by checking it with ball gauge ( it cannot pass ), but we are not aware of the circumstances when it was detected.We checked the image with the borescope and the channel was blocked by some soft material.We enquired with our sales rep who attended the hospital where the scope was being used.The customer reported no issue with the op channel being blocked.From the images provided, it seems to be debris suction from within patient (as a routine procedure), however, we cannot be 100% sure.Investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.

• Brand Name: PENTAX
• Type of Device: PENTAX MEDICAL VIDEO COLONOSCOPE EC38-I20C SERIES
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 19600 12; JA 1960012
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 19600 12; JA 1960012
• Manufacturer Contact: gurvinder nanda ; 3 paragon drive; montvale, NJ 07645 ; 2015712318
• MDR Report Key: 18395734
• MDR Text Key: 331581992
• Report Number: 9610877-2023-00296
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04961333251896
• UDI-Public: 04961333251896
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K231249
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EC38-I20CL
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1