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

Model Number EG29-I10

Device Problem Mechanical Problem (1384)

Patient Problem Nausea (1970)

Event Date 06/05/2022

Event Type  Injury  

Manufacturer Narrative

International medical device regulators forum (imdrf) adverse event reporting.(b)(4).The investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.

Event Description

Pentax medical was made aware of an event on (b)(6) 2022 that occurred in china within the apac region in the operating room during use.The user reported that the distal end rotated and bend, then it could not go back to straight, it was difficult to get out the endoscope.Lt was useless to rotate the angle knob repeatly.The user rotated with both hands and slowly adjust the bending part, then got out endoscope successfully.Afterwards, the patient had stomach discomfort symptoms without bleeding, but the symptoms were relieved after medication(medication information not provided).During reprocessing, the nurse found that the angle knob was out of order, due to angle wire fracture, so she contacted the equipment department for repair.This event meets the requirements for fda reportability; however submission of this report does not constitute an admission that medical personnel, user facility, importer, manufacturer or product caused or contributed to the event.

Manufacturer Narrative

F10 updated: international medical device regulators forum (imdrf) adverse event reporting remove component code: 525 tube.Evaluation summary: the pentax medical engineer checked with hospital staff and the device was used for a medical examination.The patient had stomach discomfort symptoms without bleeding, but the symptoms were relieved after medication.After that, the patient was discharged.According to the reported content, repairs by a third party (use of parts made by other companies, use of remanufactured parts) were carried out, and it was speculated that the failure was caused by the repairs by this third party.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.

Event Description

Refer to h10.

• Brand Name: PENTAX
• Type of Device: VIDEO GASTROSCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi; tokyo, 196-0 012; JA 196-0012
• MDR Report Key: 15918777
• MDR Text Key: 304837329
• Report Number: 2518897-2022-00222
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04961333211692
• UDI-Public: 04961333211692
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EG29-I10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/03/2023
• Distributor Facility Aware Date: 11/14/2022
• Device Age: 72 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/05/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/03/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other