MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO GASTROSCOPE 2.8C 9.0T 1050L

Model Number EG-2790K

Device Problem Break (1069)

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

Event Date 11/21/2023

Event Type  malfunction  

Event Description

The time of event is not during procedure.There was no report of patient harm.Video image failure(objective lens broken).

Manufacturer Narrative

The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the objective lens broken.Based on the result, we concluded that it was caused due to the excessive force applied on the objective lens.In addition, our technician confirmed that the light guide cable coating damage, the control body broken, the angle wire corroded, the forward body frame corroded, the objective gluing missing, the air/water cylinder control body deformed, the lcb distal cover glass scratched, the junction case loose, the bending rubber worn out, the distal body worn out, the segment worn out, the up pulley wire rupture, and the insertion flexible tube non-pentax work/parts; however, these defects are not the main cause, and/or irrelevant to the alleged complaint.Based on the technical report ""hr-rpt-0586(image failure)"" and/or the risk analysis results, it was evaluated to submit mdr.

• Brand Name: PENTAX
• Type of Device: VIDEO GASTROSCOPE 2.8C 9.0T 1050L
• 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: 18243957
• MDR Text Key: 329454375
• Report Number: 9610877-2023-61584
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K131902
• 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: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EG-2790K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2023
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 12/01/2023
• 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