MAUDE Adverse Event Report: Micro-Tech (Nanjing) Co.,Ltd. Single-Use Biopsy Forceps

Catalog Number	LCNBF13-10124230
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the forcep ripped versus cut with biopsy.Microtech forcep caused enough patient harm that patient was brought back for bleeding and intervention.
Additional Manufacturer Narrative
After micro-tech received this incident, we reviewed the manufacturing documents from the device history record and found no abnormalities that would contribute to this issue.We are trying to get more informaiton for investigation.We will fill a follow-up report when this incident investigation is done.

• Brand Name: Single-Use Biopsy Forceps
• Common Device Name: Forcep
• Manufacturer (Section D): Micro-Tech (Nanjing) Co.,Ltd.; no.10 gaoke third road; nanjing national hi-tech, indu; nanjing, jiangsu 21003 2; CH 210032
• Manufacturer (Section G): Micro-Tech(Nanjing) Co.,Ltd.; no.10 gaoke third road; nanjing national hi-tech, indu; nanjing, jiangsu 21003 2; CH 210032
• Manufacturer Contact: becky li ; no.10 gaoke third road; nanjing national hi-tech, ind; nanjing, jiangsu 21003-2 ; CH 210032
• MDR Report Key: 50814859
• Report Number: 3004837686-2026-00009
• Device Sequence Number: 10648436
• Product Code: FCL
• UDI-Device Identifier: 46932503540306
• UDI-Public: (01)46932503540306(11)260514(17)300513(10)M260514035
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: 510k Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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 Catalogue Number: LCNBF13-10124230
• Device Lot Number: M260514035
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2026
• 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: Other
• Patient Sex: Unknown