MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; STERILE DISTAL END CAP

Model Number	OE-A63
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Per the initial report, the first cap[dec] clicked on but detached before patient use, second cap[dec] clicked on but then detached before patient use, third cap[dec] attached and was used for a case and had difficulties removing from the endoscope.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
Pentax medical america performed good faith effort to gather additional information regarding this event, however they are unable to obtain it at this time.If additional information becomes available, a supplemental report will be filed with the new information.Manufacturer mdr 9610877-2024-00013, duodenoscope model:ed34-i10t2, serial:unknown, dec distal cap model oe-a63 lot number 0011112 manufacturer mdr 9610877-2024-00015, dec distal cap model oe-a63 lot number 0011112.
Additional Manufacturer Narrative
Evaluation summary the facility did not respond to the gfe(good faith effort).Based on the investigation, since similar problems did not occur frequently at other facilities, we determined that it was a user error, but we were unable to determine the cause.A device history record (dhr) review was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured on 24-oct-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 on 04-nov-2022 and actual date shipped were confirmed on 07-nov-2022.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.

• Brand Name: PENTAX
• Common Device Name: STERILE DISTAL END CAP
• 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: gurvinder nanda ; 3 paragon drive; montvale, NJ 07645 ; 2015712318
• MDR Report Key: 18735969
• Report Number: 9610877-2024-00014
• Device Sequence Number: 7243615
• Product Code: FDT
• UDI-Device Identifier: 04961333226153
• UDI-Public: 04961333226153
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K192245
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2024

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-A63
• 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: 01/26/2024
• Supplement Date Received by Manufacturer: 01/26/2024
• Initial Report FDA Received Date: 02/19/2024
• Supplement Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown