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

Model Number EG-2990I

Device Problems Break (1069); Fluid/Blood Leak (1250); Poor Quality Image (1408)

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

Event Date 09/18/2023

Event Type  malfunction  

Event Description

Blurred image during use, water streaks inside, stopped using it.Harm performance: affect the doctor's clinical diagnosis of the patient, resulting in the examination not being able to be performed.Defect performance: blurry image, bending rubber leak, instrument channel lnlet leak, tight angle, down angulation defect and air/water supply clogged.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.

Manufacturer Narrative

Pentax medical china performed good faith effort to gather additional information regarding this event and provided an email response on 31-oct-2023 with the following questions.- the procedure was completed using an alternative scope.- the impact on patients of discontinuing use.Pentax medical china said no feedback form engineer up to now.Checked the report content form cfda again, the hospital did not mention patient harm when reporting this case, we think that the defect affected the physician's clinical diagnosis of the patient, resulting in the endoscopy not being able to be performed, but no harm was caused to the patient.Investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.

Manufacturer Narrative

Correction information b4: date of this report g6: follow up #1 h2:if follow-up, what type? based on the content of the complaint that ""blurred image during use, water streaks inside, stopped using it." it was determined that mdr was required.However, the apac investigation on 15-dec-2023 determined that this complaint was misreporting of the incident.We created decision tree again and judged "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 COLONO SCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 19600 12; JA 1960012
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 19600 12; JA 1960012
• Manufacturer Contact: william goeller ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 18089197
• MDR Text Key: 327779443
• Report Number: 9610877-2023-00249
• Device Sequence Number: 1
• Product Code: FDS
• 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: 12/25/2023

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
• Device Operator: Health Professional
• Device Model Number: EG-2990I
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2023
• Initial Date FDA Received: 11/07/2023
• Supplement Dates Manufacturer Received: 10/11/2023
• Supplement Dates FDA Received: 12/25/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1