MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO SIGMOIDOSCOPE 4.2C 12.8T 700L FWJ

Model Number ES-3870K

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 07/11/2023

Event Type  malfunction  

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 fluid damage, the objective lens cracked, the lg connector corroded, the distal body worn out, and the u/d and the r/l knobs white marking faded/missing; however, these defects are not the main cause, and/or irrelevant to the alleged complaint.In terms of the 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.

Event Description

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

• Brand Name: PENTAX
• Type of Device: VIDEO SIGMOIDOSCOPE 4.2C 12.8T 700L FWJ
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishisima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishisima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer Contact: william goeller ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 17411538
• MDR Text Key: 319949610
• Report Number: 9610877-2023-57029
• Device Sequence Number: 1
• Product Code: FAM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951577
• 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: 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ES-3870K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2023
• 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