MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; CLEANING BRUSH

Model Number	CS6021SN
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4: this device is not distributed in the usa; therefore, the pma/510(k) number is not applicable.The pentax medical manufacturing department responded to a good faith effort request via email on 06-sep-2024 as follows information.For cleaning brushes, inspection in the manufacturing department involves measuring the outside dimensions at several points.Any part of the brush that is thin is likely to be rejected based on the outer diameter.The cleaning brushes in this case are likely to be judged as abnormal products in the inspection process of manufacturing.Investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.
Event or Problem Description
Brush oval cut at the front instead of round as before.This event occurred at the time of before 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
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.Additional information: d4: primary unique device identifier (udi) #.H4: device manufacture date.The 510(k) number is not applicable.Based on the investigation data that the potential cause/root cause of the failure was lateral compression.The dhr review confirmed the endoscope was manufactured on 09-feb-2024 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 09-feb-2024 and actual date shipped were confirmed on 13-feb-2024.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.

• Brand Name: PENTAX
• Common Device Name: 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: 20197007
• Report Number: 9610877-2024-00088
• Device Sequence Number: 7649643
• Product Code: MNL
• UDI-Device Identifier: 04961333063932
• UDI-Public: (01)04961333063932(11)240209(10)0011024
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2024

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
• Device Model Number: CS6021SN
• Device Lot Number: 0011024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown