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

Model Number EG29-I10C

Device Problem Partial Blockage (1065)

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

Event Date 04/21/2023

Event Type  malfunction  

Event Description

Patient involved - no known adverse event.Customer reported during a procedure their staff, along with the physician tried to pass a snare through the instrument inlet port.They stated it was extremely hard to pass the snare.Description of any actions taken: snare was removed and replaced numerous times until it was able to pass from the scopes.This event occurred at the time of during use.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

Investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.

Manufacturer Narrative

Correction information: h6: coding changed, based on the investigation result.Evaluation summary: based on the content of investigated data.It was determined, that the potential cause/root cause of failure was that excessive force, such as hitting the root brace part, during use or hitting the root brace part against the treatment table with the operation part upright, was applied and the forceps channel was deformed.Making it difficult for the treatment instrument to pass through.A device history record (dhr) review was performed by the manufacturer.The dhr review confirmed, the endoscope was manufactured pentax medical penang on 20-jun-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 21-jun-2022.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; akishima-shi, tokyo 19600 12; JA 1960012
• 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: 16908549
• MDR Text Key: 314981935
• Report Number: 9610877-2023-00120
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04961333237586
• UDI-Public: 04961333237586
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190805
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 07/20/2023

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: EG29-I10C
• Initial Date Manufacturer Received: 04/21/2023
• Initial Date FDA Received: 05/10/2023
• Supplement Dates Manufacturer Received: 04/21/2023
• Supplement Dates FDA Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1