MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO GASTROSCOPE

Model Number EG16-K10

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 unknown.There was no report of patient harm.Video image failure(objective lens broken).

Manufacturer Narrative

This device is classified as import for export, therefore 510k is not applicable.Model eg-1690k is available in the usa with a 510k number k131902.The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the ccd module with drive pcb objective lens cracked.Based on the result, we concluded that it was caused due to the excessive force applied on the ccd module with drive pcb.In addition, our technician confirmed that the air/water nozzle missing, the operation channel (primary) leak, and the lcb distal cover glass dirty; 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
• 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: 18243938
• MDR Text Key: 330669845
• Report Number: 9610877-2023-61576
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: EG16-K10
• 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