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

Model Number EC-3890LI

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/11/2024

Event Type  malfunction  

Event Description

The time of event is unknown.There was no report of patient harm.Air/water nozzle peeled off (black glue).

Manufacturer Narrative

The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the nozzle gluing missing.Based on the result, we concluded that it was caused due to the physical damage applied on the nozzle gluing.In addition, our technician confirmed that the lg connector broken, the bending rubber leak, the remote control buttons leak, and the bending rubber cut; however, these defects are not the main cause, and/or irrelevant to the alleged complaint.In terms of the nozzle glue missing, the possibility of dropping into human body could not be denied.Moreover, based on the technical report""hr-rpt-0585(nozzle)"" and/or the risk analysis results, it was evaluated to submit mdr.

• 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: gurvinder nanda ; 3 paragon drive; montvale, NJ 07645 ; 2015712318
• MDR Report Key: 18976744
• MDR Text Key: 338759369
• Report Number: 9610877-2024-52461
• 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: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2024
• 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