MAUDE Adverse Event Report: HANGZHOU AGS MEDTECH CO.,LTD. AGS; DISPOSABLE SWINGING BIOPSY FORCEPS

Model Number	AG-50212-2823
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Symbol for scope size is incorrect on pouch, case, and box label.Label file and approved labels are for 3.2mm, the product in stock shows 2.8mm scope in the symbol section of the labels, but the products size itself is correct.
Additional Manufacturer Narrative
Containments we have already made: (1) after verifying that it is just a label template error, corrected the error and print out the product label correctly; (2)the remaining products with incorrect labels will be scraped, and the company will compensate for the correctly labeled products.

• Brand Name: AGS
• Common Device Name: DISPOSABLE SWINGING BIOPSY FORCEPS
• Manufacturer (Section D): HANGZHOU AGS MEDTECH CO.,LTD.; building 5, building 6, no.597; hangzhou, zhejiang ; CH
• Manufacturer (Section G): HANGZHOU AGS MEDTECH CO.,LTD.; building 5, building 6, no.597; hangzhou, zhejiang 31000 6; CH 310006
• Manufacturer Contact: hu mei ; building 5, building 6, no.597 kangxin road; hangzhou, zhejiang 31000-6 ; CH 310006
• MDR Report Key: 17993315
• Report Number: 3010288205-2023-00001
• Device Sequence Number: 6754507
• Product Code: FCL
• UDI-Device Identifier: 20816734023123
• UDI-Public: (01)20816734023123
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: N/AN/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/07/2023

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 Expiration Date: 07/31/2025
• Device Model Number: AG-50212-2823
• Device Catalogue Number: 502
• Device Lot Number: 0604669
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/19/2023
• 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