MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO UPPER G.I.SCOPE

Model Number EG29-I10

Device Problem Poor Quality Image (1408)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.We performed good faith effort to gather additional information regarding this event, however we couldn't obtain it.Upon inspection, defects were detected in the cable and ccd camera.

Event Description

Customer reports image failure.Video gastroscope without leak.This event occurred at the time of during use.There was no report of patient harm.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.

Event Description

Pentax of america, inc.Performed several good faith effort attempts to gather additional information regarding an initial customer reported on 30-nov-2023 of an image failure during use without leak and no patient harm involving video gastroscope model eg29-i10 serial number (b)(6).The user finally provided an email response on 11-jan-2024 with the following responses including a delay in the procedure which would require medical intervention such as additional anesthesia or prolonged hospital stay questions.Additionally, they noted the delay or medical intervention put the patient at risk for adverse events.In response to the above reply, pentax of america, inc.Submitted another set of questions again to gather further information, but have not yet received a response.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.Customer reports image failure.Video gastroscope without leak.

Manufacturer Narrative

H6 continued: international medical device regulators forum (imdrf) adverse event reporting health effect - clinical code (e): 4580 insufficient information.Health effect - impact code (f): 4604 delay to treatment/ therapy, 4648 insufficient information.Medical device problem code (a): 1408 poor quality image.Component code (g): 427 circuit board 841 imager.Type of investigation (b): 3331 analysis of production records, 10 testing of actual/suspected device.Investigation findings (c): 3243 stress problem identified, 180 mechanical problem identified investigation conclusions (d): 4307 cause traced to component failure.Evaluation summary: based on the investigation, during the inspection defects were detected in the cable and ccd camera.A potential root cause of these failures are physical impact (vibration, drop, shock) or fluid damage to ccd driver pcb.Physical impact (vibration, drop, shock) or fluid damage to ccd driver pcb occured image failure.A definitive root cause of the reported issue could not be identified.A device history record(dhr) review was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured pentax medical miyagi on 1-nov-2022 under normal conditions, passed all required inspections, and was released accordingly.Also, there were no reworks or concessions and the dates of approval for shipment and actual date shipped were confirmed on 1-nov-2022.Pentax medical america performed good faith effort to gather additional information regarding this event and provided an email response on 11-jan-2024 with the following questions.Q.Was the procedure for treatment or diagnostic purposes? a: treatment.Q.Was the patient already prepped for the procedure? a :yes.Q: was there a delay in the procedure which would require medical intervention such as additional anesthesia or prolonged hospital stay? a: yes.Q: did the delay or medical intervention put the patient at risk for adverse events? a: yes.Q: if this event involves a stuck accessory, did the accessory became stuck during the current procedure? a: no.Q: was the product used to complete the procedure? a: no.Q: was the procedure completed with another similar device? a: no.Q: was the procedure completed? a: no.Q: if the procedure was cancelled, was the procedure performed on another day? a: no.Rescheduled procedure pending.Q: was the patient recalled for further screening? a: no.Q: was the product removed from circulation immediately after the failure/event occurred and subsequently called in for service/replacement? a: yes.In response to the above reply, pentax medical america asked the customer the following questions again to gather further information, but did not receive a response.Q: it is described as a procedure for treatment, but what kind of treatment did they have? q: why couldn't the procedure be completed? i would like to know the reason, whether it was because they did not have a replacement scope, the patient's condition, or whether they had already determined that the procedure was not necessary.Q : why don't you do the procedure on another day? same as above, i would like to know the reason.Q: patient's current condition.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 UPPER G.I.SCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishimashi, tokyo 196-0 012; JA 196-0012
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishimashi, tokyo 196-0 012; JA 196-0012
• Manufacturer Contact: gurvinder nanda ; 3 paragon drive; montvale, NJ 07645 ; 2015712318
• MDR Report Key: 18379852
• MDR Text Key: 331206174
• Report Number: 9610877-2023-00276
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04961333248315
• UDI-Public: 04961333248315
• Combination Product (y/n): N
• Reporter Country Code: PE
• PMA/PMN Number: K131902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• 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?: No
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization