MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO CYSTO SCOPE

Model Number ECY-1575K

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 01/23/2024

Event Type  Injury  

Manufacturer Narrative

This device is not distributed in us so that 510k is blank.After the cystoscopy, a patient felt uncomfortable and visited a medical institution (dermatology).At that time, the possibility of a nickel allergy was pointed out to the patient.This product does not contain nickel in any parts that come into direct contact with patients.However, since nickel is contained in the parts that come into indirect contact.Pentax medical japan performed good faith effort to gather additional information regarding this event.The patient visited another medical institution, but further details were not available.There are no complaints of the following symptoms at this time.- serious health damage - medical or surgical intervention - deterioration of health damage - further examination of the patient additionally, we were unable to obtain information on the specific parts of the body that showed allergic reactions.Investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.Continued: international medical device regulators forum (imdrf) adverse event reporting health effect - clinical code: 1907 hypersensitivity/allergic reaction health effect - impact code: 4606 exacerbation of existing condition medical device problem code 2993 adverse event without identified device or use problem component code: 4755 part/component/sub-assembly term not applicable type of investigation: 4118 type of investigation not yet determined investigation findings: 3233 results pending completion of investigation conclusions: 11 conclusion not yet available.

Event Description

After the cystoscopy with ecy-1575k, the patient felt uncomfortable, so he visited another medical institution (dermatologist) and was told that he might have a nickel allergy.I was asked if i use nickel in my scopes.The intravesical examination was completed without any problems.This event occurred at the time of after 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

H6 continued: international medical device regulators forum (imdrf) adverse event reporting health effect - clinical code: 1907 hypersensitivity/allergic reaction.Health effect - impact code: 4606 exacerbation of existing condition.Medical device problem code 2993 adverse event without identified device or use problem component code: 4755 part/component/sub-assembly term not applicable.Type of investigation: 3331 analysis of production records.Investigation findings: 213 no device problem found.Investigation conclusions: 67 no problem detected.Evaluation summary: a gfe was performed but no additional information was obtained.The endoscope was used for observation only and no biopsy.Investigation revealed that there was no nickel in the scope's direct or joint contact areas.Therefore, allergic symptoms may have been caused by other treatment tools or equipment.Pentax medical verbally explained to the customer in the attached document that we do not use nickel parts.A device history record(dhr) review was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured pentax medical miyagi on 17-aug-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 17-aug-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 CYSTO SCOPE
• 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: 18647699
• MDR Text Key: 334611594
• Report Number: 9610877-2024-00004
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ECY-1575K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/05/2024
• Supplement Dates Manufacturer Received: 01/24/2024
• Supplement Dates FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Sex: Female