MAUDE Adverse Event Report: CORBIN CLINICAL RESOURCES, LLC PRECISIONPOINT TRANSPERINEAL ACCESS SYSTEM; BIOPSY NEEDLE

Model Number	P1002
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	03/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the reported transperineal access system kit was not provided.A ship history review was performed.The review identified the most likely lot number as l/n 3418090000.A customer shipped history showed orders of 5 devices of lot s/l (b)(6) being shipped approximately every 8 weeks.Five devices were supplied on (b)(6) 2025, and five were supplied on (b)(6) 2025.The review also identified lot l/n 3424110000 shipped to this customer until (b)(6) 2025.Based on the ship history review, it is likely that lot l/n 3418090000 was utilized on the date of event.A device history record review completed on lot l/n 3418090000, confirmed that it met manufacturer specification prior to release.Follow-up with the user facility confirmed that no medical intervention was necessary due to this needle puncture, and the nurse was fine.Based on the information available, a conclusion code of adverse event related to procedure was assigned to this investigation.Most likely lot 3418090000 udi: (b)(4) expiration date: 09-16-2027.
Event or Problem Description
It was reported that there was difficulty removing the trocar from the second to bottom aperture of the carriage.The nurse pulled out the trocar from the carriage but inadvertently poked her middle finger with the access needle.It was noted that the nurse washed and sanitized the needle puncture and placed a band-aid.A precautionary patient blood test was performed to determine if any further action was required.
Event or Problem Description
It was reported that there was difficulty removing the trocar from the second to bottom aperture of the carriage.The nurse pulled out the trocar from the carriage but inadvertently poked her middle finger with the access needle.It was noted that the nurse washed and sanitized the needle puncture and placed a band-aid.A precautionary patient blood test was performed to determine if any further action was required.
Additional Manufacturer Narrative
B1 adverse event/product problem - corrected based on investigation.H1 type of reportable event - corrected based on investigation.The lot number for the reported transperineal access system kit was not provided.A ship history review was performed.The review identified the most likely lot number as l/n 3418090000.A customer shipped history showed orders of 5 devices of lot s/l 3418090000 being shipped approximately every 8 weeks.Five devices were supplied on 21 january 2025, and five were supplied on 13 march 2025.The review also identified lot l/n 3424110000 shipped to this customer until 29 april 2025.Based on the ship history review, it is likely that lot l/n 3418090000 was utilized on the date of event.A device history record review completed on lot l/n 3418090000, confirmed that it met manufacturer specification prior to release.Follow-up with the user facility confirmed that no medical intervention was necessary due to this needle puncture, and the nurse was fine.Based on the information available, a conclusion code of adverse event related to procedure was assigned to this investigation.Most likely lot 3418090000 udi: (b)(4) expiration date: 09-16-2027.
Additional Manufacturer Narrative
B1 adverse event/product problem - corrected based on investigation.H1 type of reportable event - corrected based on investigation.H11 additional mfr narrative - risk assessment added.The lot number for the reported transperineal access system kit was not provided.A ship history review was performed.The review identified the most likely lot number as l/n 3418090000.A customer shipped history showed orders of 5 devices of lot s/l (b)(6) being shipped approximately every 8 weeks.Five devices were supplied on 21 january 2025, and five were supplied on 13 march 2025.The review also identified lot l/n 3424110000 shipped to this customer until 29 april 2025.Based on the ship history review, it is likely that lot l/n 3418090000 was utilized on the date of event.A device history record review was completed on lot l/n 3418090000, and the review confirmed that it met manufacturer specification prior to release.In addition, a review of the p1002 hazard analysis was completed and confirmed that the event of physical resistance post use was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Follow-up with the user facility confirmed that no medical intervention was necessary due to this needle puncture, and the nurse was fine.Based on the information available, a conclusion code of adverse event related to procedure was assigned to this investigation.Most likely lot 3418090000 udi: (b)(4) , expiration date: 09-16-2027.
Event or Problem Description
It was reported that there was difficulty removing the trocar from the second to bottom aperture of the carriage.The nurse pulled out the trocar from the carriage but inadvertently poked her middle finger with the access needle.It was noted that the nurse washed and sanitized the needle puncture and placed a band-aid.A precautionary patient blood test was performed to determine if any further action was required.

• Brand Name: PRECISIONPOINT TRANSPERINEAL ACCESS SYSTEM
• Common Device Name: BIOPSY NEEDLE
• Manufacturer (Section D): CORBIN CLINICAL RESOURCES, LLC; 183 north centre street; cumberland MD 21502
• Manufacturer (Section G): PARAGON MEDICAL - MANSFIELD; 11 forbes blvd ste 101; mansfield MA 02048
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23843488
• Report Number: 2124215-2025-91845
• Device Sequence Number: 9816845
• Product Code: FCG
• UDI-Device Identifier: B371P10020
• UDI-Public: B371P10020
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K160423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/13/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: P1002
• Device Catalogue Number: P1002
• 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: 03/21/2025
• Supplement Date Received by Manufacturer: 01/13/2026; 03/26/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 01/27/2026; 04/13/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PRECISION POINT BIOPSY NEEDLE GUIDE; PRECISION POINT BIOPSY NEEDLE GUIDE; PRECISION POINT BIOPSY NEEDLE GUIDE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown