MAUDE Adverse Event Report: MEDICAL ACTION INDUSTRIES KIT: CIRCUMCISION 20/CS

Model Number	56779
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Incident 5 of 5 the product involved in the event is not available for evaluation.A follow-up report will be provided upon conclusion of investigation.Medical action industries is the manufacturer of the circumcision convenience kit containing the complaint straight hemostat component, r0598 (lots 2541r0598 & 2441r0598g).The two lots manufactured in the complaint convenience kit lot were sourced from two different suppliers, global instruments inc.(fda registration 1057200) & tamzon instruments, inc.(fda registration 1421530).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.
Event or Problem Description
Straight hemostat broke during circumcision procedure.The hemostat instrument failed to hold the skin, coming loose.No patient harm resulted from incident.Site reported the hemostat failed 4-5 times during 19 total circumcisions performed.

• Brand Name: KIT: CIRCUMCISION 20/CS
• Common Device Name: KIT: CIRCUMCISION 20/CS
• Manufacturer (Section D): MEDICAL ACTION INDUSTRIES; 25 heywood road; arden NC 28704
• Manufacturer (Section G): MEDICAL ACTION INDUSTRIES; 25 heywood road; arden NC 28704
• Manufacturer Contact: nichole coggins ; 25 heywood road; arden, NC 28704 ; 8287820529
• MDR Report Key: 25145142
• Report Number: 1030451-2026-00016
• Device Sequence Number: 9213096
• Product Code: OHG
• UDI-Device Identifier: 20809160006020
• UDI-Public: 20809160006020
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2026

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: 56779
• Device Catalogue Number: 56779
• Device Lot Number: 340235
• Was Device Available for Evaluation?: No
• 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: Not provided
• Supplement Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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