MAUDE Adverse Event Report: MEDICAL ACTION INDUSTRIES UNIVERSAL CIRCUMCISION KIT

Model Number	79069B
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The curved hemostat failed to hold during the procedure, as the instrument tips would not remain secured or locked in place.Reporter indicated there was a delay of a few minutes.Residents in-training stated they feel intimidated when the hemostats do not hold up during circumcision procedure and can cause cosmetic issues.
Additional Manufacturer Narrative
The product involved in the event is said to be available but has not been received yet.A follow-up report will be provided upon conclusion of investigation.Medical action industries is the manufacturer of the convenience kit containing the complaint component: (b)(4), lot: 25381161pp purchased from specification developer, global instruments inc.(fda registration 1057200).This product incident is documented in the complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that product is defective or has caused serious injury.
Additional Manufacturer Narrative
Two curved hemostat samples were received in a biohazard bag.Visual inspection through the bag showed light passing through the tips of the hemostats while in the closed position, confirming the reported failure.A review of the device history records identified no nonconformances during the production period.At the time the complaint was received, there was no remaining inventory from either the complaint kit lot or the associated instrument lot available for evaluation.Trending analysis also indicated no significant patterns related to this kit or this type of issue involving the instrument.The hemostat lots in question were manufactured prior to the full implementation of corrective actions by the supplier, global instruments, inc.Corrective actions formerly implemented by the supplier (global instruments, inc.) include enhanced functional inspections with a focus on jaw alignment, locking mechanism engagement, and gripping force.Inspection criteria and expectations have also been reinforced with both quality assurance and production teams, with implementation completed on 01/23/2026.The supplier was notified on 03/20/2026 of this complaint.This product incident is documented in the complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that product is defective or has caused serious injury.

• Brand Name: UNIVERSAL CIRCUMCISION KIT
• Common Device Name: UNIVERSAL CIRCUMCISION KIT
• Manufacturer (Section D): MEDICAL ACTION INDUSTRIES; 25 heywood road; arden NC 28704
• Manufacturer (Section G): GLOBAL INSTRUMENTS INC.; 746 tucker road; ste 1; winder GA 30680
• Manufacturer Contact: nichole coggins ; 25 heywood road; arden, NC 28704 ; 8287820529
• MDR Report Key: 24617453
• Report Number: 1030451-2026-00007
• Device Sequence Number: 21366838
• Product Code: OHG
• UDI-Device Identifier: 20809160410407
• UDI-Public: 20809160410407
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2026

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 Model Number: 79069B
• Device Catalogue Number: 79069B
• Device Lot Number: 337986
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2026
• 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
• Patient Sex: Unknown