MAUDE Adverse Event Report: Allied Medical LLC. GOMCO; 500S CIRC. CLAMP EX SMALL 1.1

Model Number	02-00-0500
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Genital Bleeding (4507)
Date of Event	07/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Bleeding on the crushline of the foreskin, happening with new 1.1 clamps.( could also be another size).
Additional Manufacturer Narrative
According to the customer, a circumcision procedure was performed using a gomco clamp, and there was an increase in bleeding at the crushline of the foreskin.The customer stated that, when tightening the clamp nut, the nut was bottoming out and that mixed parts were present on the clamp.Surgiseal was used.The circumcision was completed without any further issues.The facility stated there was no serious injury.The returned clamp has been received and is currently undergoing investigation and evaluation.The investigation remains ongoing, and no final determination regarding the cause of the reported event has been made at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: GOMCO
• Common Device Name: 500S CIRC. CLAMP EX SMALL 1.1
• Manufacturer (Section D): Allied Medical LLC.; 13622 lakefront drive; earth city MO 63045
• Manufacturer (Section G): Allied Medical LLC; 13622 lakefront drive; earth city MO 63045
• Manufacturer Contact: nicole szakats ; 13622 lakefront drive; earth city, MO 63045 ; +1(314)771-2400
• MDR Report Key: 50266699
• Report Number: 1924066-2026-00011
• Device Sequence Number: 10584542
• Product Code: HFX
• UDI-Device Identifier: 00026072002292
• UDI-Public: 00026072002292
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: Preamendment
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2026

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?: No
• Device Model Number: 02-00-0500
• Device Catalogue Number: 02-00-0500
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/29/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 08/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown