MAUDE Adverse Event Report: SEIRIN CORPORATION SEIRIN ACUPUNCTURE NEEDLE

Model Number	J-TYPE NO.3(0.20)×60MM
Medical Device Problem Code	Insufficient Information (3190)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual product was not available for recovery or inspection.No abnormalities were identified in the manufacturing records.No similar complaints have been reported from the market.Due to limited cooperation from the medical institution, the pmda report was closed as "details unknown." since we have determined that this incident was not to be device-related, no recall or corrective action is necessary.
Event or Problem Description
Seirin j-type no.3 (dia0.20)×60mm acupuncture needles were used during the acupuncture treatment.After 5-10 minutes of treatment, when the acupuncturist removed the needles, one top of the needle was found remained inside the body of the patient.At this moment, the top of the needle, as well as the removed needle shaft, have not been retrieved yet.

• Brand Name: SEIRIN ACUPUNCTURE NEEDLE
• Common Device Name: ACUPUNCTURE NEEDLE
• Manufacturer (Section D): SEIRIN CORPORATION; 147 ouchi; shimizu-ku; shizuoka, shizuoka 424-0 061; JA 424-0061
• Manufacturer (Section G): SEIRIN CORPORATION; 147 ouchi; shimizu-ku; shizuoka, shizuoka 424-0 0614; JA 424-006142
• Manufacturer Contact: 147 ouchi; shimizu-ku; shizuoka, shizuoka 424-0-061
• MDR Report Key: 22484536
• Report Number: 3003135788-2025-00001
• Device Sequence Number: 8245346
• Product Code: MQX
• UDI-Device Identifier: 04547248701246
• UDI-Public: 04547248701246
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2025

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
• Operator of Device: Health Professional
• Device Model Number: J-TYPE NO.3(0.20)×60MM
• Device Lot Number: 24513G7
• 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: 12/06/2024
• Initial Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian