MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; BALLOON

Model Number	OE-A61
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is not distributed in us so that 510k is blank.Investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.
Event or Problem Description
During the demonstration, the balloon tore inside the patient's body.As a result of customer feedback, no patient incidents nor fragment let inside a patient.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.
Additional Manufacturer Narrative
Evaluation summary when the balloon was attached to the endoscope, it is potential that the strength of the balloon was decreased due to that the balloon was excessively stretched, or that the balloon was rubbed with the tip of the endoscope.A device history record (dhr) review was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured on 24-apr-2023 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 25-apr-2023.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.

• Brand Name: PENTAX
• Common Device Name: BALLOON
• 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: gurvinder nanda ; 3 paragon drive; montvale, NJ 07645 ; 2015712318
• MDR Report Key: 18647302
• Report Number: 9610877-2024-00006
• Device Sequence Number: 7055820
• Product Code: EOQ
• UDI-Device Identifier: 04961333123339
• UDI-Public: 04961333123339
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K183516
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2024

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: OE-A61
• Device Lot Number: 1011043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2024
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 02/05/2024
• Supplement Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown