MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; PENTAX MEDICAL PROFILE SINGLE-USE CLEANING BRUSH

Model Number	CS2022A
Medical Device Problem Codes	Product Quality Problem (1506); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Per the initial report, pentax incorrectly processed an order ((b)(6) 2024) for brushes by transacting brush cs2022a lot #0022404 instead of cs5522a two boxes.Customer received and used 5 brushes out of 1 box of 50 (received (b)(6) 2024).Customer mentioned they did not notice right away that it was an incorrect brush.The two boxes were returned inside the box for cs5522a, confirmed by customer (b)(6) 2024.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
G4: this device is not distributed in the usa, therefore the pma/510(k) number is not applicable.Investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.9610877-2024-00116_cs2022a_0022404_incorrect brushes, 9610877-2024-00117_cs2022a_0022404_incorrect brushes, 9610877-2024-00118_cs2022a_0022404_incorrect brushes, 9610877-2024-00119_cs2022a_0022404_incorrect brushes, 9610877-2024-00120_cs2022a_0022404_incorrect brushes.
Additional Manufacturer Narrative
Correction information: b4: date of this report.G6: follow up #1.H2: if follow-up, what type? h3: device evaluated by manufacture.H6: coding changed based on the investigation result.Evaluation summary: besed on the investigation has confirmed that the customer ordered 2x cs5522a and pentax medical cadanda processed the order for 2x cs2022a.The r&d department of pentax medical japan conducted validation test of reprocessing without brushing for i10c and i20c scopes.The results confirmed that there was no impact on reprocessing even if the customer used the wrong brush for reprocessing.A device history record(dhr) review was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured on 04-apr-2024 under normal conditions, passed all required inspections, and was released accordingly.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.9610877-2024-00116_cs2022a_0022404_incorrect brushes.9610877-2024-00117_cs2022a_0022404_incorrect brushes.9610877-2024-00118_cs2022a_0022404_incorrect brushes.9610877-2024-00119_cs2022a_0022404_incorrect brushes.9610877-2024-00120_cs2022a_0022404_incorrect brushes.

• Brand Name: PENTAX
• Common Device Name: PENTAX MEDICAL PROFILE SINGLE-USE CLEANING BRUSH
• 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: 20342291
• Report Number: 9610877-2024-00120
• Device Sequence Number: 15467110
• Product Code: MNL
• UDI-Device Identifier: 14961333221582
• UDI-Public: (01)14961333221582(11)240404(10)0022404
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2024

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: CS2022A
• Device Lot Number: 0022404
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2024
• 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