MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO GASTROSCOPE - I10 STANDARD

Model Number EG29-I10

Device Problem Break (1069)

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

Event Date 01/25/2024

Event Type  malfunction  

Manufacturer Narrative

The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the angle wire broken.Based on the result, we concluded that it was caused due to the excessive force applied on the angle wire.In addition, our technician confirmed that the bending rubber leak, the remote control buttons leak, the bending rubber cut, the remote control buttons cut, and the distal body worn out; however, these defects are not the main cause, and/or irrelevant to the alleged complaint.As a result of confirming the detail as gfe, no response was obtained, so we cannot deny the possibility of the angle stuck.Therefore, based on the technical report ""hr-rpt-0587(angle)"" 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.Angle wire cut.

Manufacturer Narrative

Additional information as a result of investigation in pentax medical america on february 21, 2024, it was found that the angulation was not stuck in j-position.Based on the result, we have re-evaluated the decision tree and determined that this event is not reportable.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.

• Brand Name: PENTAX
• Type of Device: VIDEO GASTROSCOPE - I10 STANDARD
• 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: gurvinder nanda ; 3 paragon drive; montvale, NJ 07645 ; 2015712318
• MDR Report Key: 18700709
• MDR Text Key: 335300404
• Report Number: 9610877-2024-51262
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EG29-I10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2024
• 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