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

Model Number	EG-3270UK
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: it was caused due to the light guide plug worn out.In addition, we confirmed that light guide cable buckle, the suction channel buckle, the us connection cable buckle, and the operation channel perforation, however, these are not related to the alleged complaint.Detail of capa (b)(4).Root cause: thin-film resistor manufactured by susumu has less durability to wet dirt or dust, resulting in electric corrosion.For this component, there was no design standard to select the component.Countermeasure: an inorganic protective film is applied to the protective coat by a cvd (chemical vapor deposition) method to improve adhesion and airtightness, thereby preventing deterioration of adhesion due to corrosion and preventing foreign matter in the resistance film.Alternative use of rg series to prevent intrusion.In the resistance sweat resistance evaluation test of the manufacturer, the failure rate is lower than that of the company's products and other companies' products, and there are no cases of similar defect reports of resistance pattern disappearance in the highly reliable rg series by inquiring.Correction: design change for the resistor concerned of epk-3000.Corrective action:document this issue as design standard and share the event and provide training for npi processor that is newly designed in future.Risk assessment result: low ex-080-0007 pm-210030.Estimated hazardous situation:unclear/loss of observation images.*unable to continue the endoscopy.Objective: patients.Occurrence: during hemostasis, "number of cases : (b)(4) cases, number of complaints : (b)(4) complaints, occurrence frequency :(b)(4)%".Based on the above, it is judged that the probability of occurrence of the estimated harm is rare and risk is low.As a result of risk assessment, no field corrective action is planned at this moment.Pentax will change design process and provide training for npi process that is newly designed in future.This report is being filed as part of the pentax backlog management plan.
Event or Problem Description
This time of event is unknown.There was no report of patient harm.Light guide plug corroded.This model should be covered by (b)(4) also.

• Brand Name: PENTAX
• Common Device Name: LINEAR ULTRASOUND VIDEO GASTROSCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 19600 12; JA 1960012
• MDR Report Key: 12285954
• Report Number: 9610877-2021-10368
• Device Sequence Number: 3165426
• Product Code: ODG
• UDI-Device Identifier: 04961333233793
• UDI-Public: 04961333233793
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K182004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 08/06/2021

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
• Operator of Device: Health Professional
• Device Model Number: EG-3270UK
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1