MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; HDVIDEO COLONOSCOPE 3.8C 13.2T 1700L FWJ

Model Number EC-3890LI

Device Problems Partial Blockage (1065); Obstruction of Flow (2423); Failure to Eject (4010)

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

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

If additional information becomes available, a supplemental report will be filed with the new information.

Event Description

Low water (cannot clear lens), low air (poor insufflation).There was no report of patient harm.The time of event is unknown.Date of event: not known for the exact date, we just know the year the complaint was sent in to manufacturer.

Manufacturer Narrative

Correction information: g6: follow up #1; h2:if follow-up, what type?; h3:device evaluated by manufacture; h6: coding changed based on the investigation result.Additional information: h4:device manufacture date.Evaluation summary: we checked the returned unit and confirmed that the air nozzle clogged.Based on the result, we concluded that it was caused due to the insufficient reprocessing at the facility.In addition, we confirmed that the lg root brace rubber cut, and the root brace rubber cut; however, they are not the main cause, and/or irrelevant to the alleged complaint.

• Brand Name: PENTAX
• Type of Device: HDVIDEO COLONOSCOPE 3.8C 13.2T 1700L FWJ
• 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 ; 8004315880
• MDR Report Key: 13766417
• MDR Text Key: 297139538
• Report Number: 9610877-2022-00338
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04961333129430
• UDI-Public: 04961333129430
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EC-3890LI
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Congenital Anomaly