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

Model Number EG29-I10

Device Problems Mechanical Problem (1384); Unintended Movement (3026)

Patient Problem Nausea (1970)

Event Date 06/05/2022

Event Type  Injury  

Event Description

The distal end rotated and bended , then it could not back to straight, it was difficult to get out the scope.Lt was useless to rotated the angle knob repeatedly.The user rotated with both hands and slowly adjust the bending part, then got out scope successfully.Afterwards, the patient had stomach discomfort symptoms without bleeding, but the symptoms were relieved after medication.During reprocessing , the nurse found that the angle knob was out of order, due to angle wire fractured,so she contacted the equipment department for repair.The time of event is during use.

Manufacturer Narrative

If additional information becomes available, a supplemental report will be filed with the new information.

Manufacturer Narrative

Correction information: g6: follow up #1 h2: if follow-up, what type? h3: device evaluated by manufacture h6: coding changed based on the investigation result.D4: unique identifier (udi) h4: device manufacture date.Evaluation summary: the pentax engineer checked with hospital staff.The device was used for 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.

• Brand Name: PENTAX
• Type of Device: VIDEO GASTROSCOPE - I10 STANDARD
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer Contact: william goeller ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 15902355
• MDR Text Key: 304683624
• Report Number: 9610877-2022-00648
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04961333211692
• UDI-Public: 04961333211692
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K131902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/06/2023

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
• Initial Date Manufacturer Received: 11/14/2022
• Initial Date FDA Received: 12/02/2022
• Supplement Dates Manufacturer Received: 11/14/2022
• Supplement Dates FDA Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other