MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP GOMCO 1.3 CIRCUMCISION DEVICE; CLAMP, CIRCUMCISION

Lot Number 2023021090

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/02/2023

Event Type  malfunction  

Event Description

During this patient's circumcision, three small metal fragments were noted during the foreskin removal process with the scalpel.This was observed by the np (nurse practitioner) and ut assisting with the procedure.These fragments did not come in contact with the head or shaft of the patient's penis.1.3 gomco was examined before and after procedure, and no abnormalities noted.Patient's member was also examined after procedure and no other fragments were noted, and this finding did not affect the cosmetic outcome of the procedure.

• Brand Name: GOMCO 1.3 CIRCUMCISION DEVICE
• Type of Device: CLAMP, CIRCUMCISION
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• MDR Report Key: 16983517
• MDR Text Key: 315759901
• Report Number: 16983517
• Device Sequence Number: 1
• Product Code: HFX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: 2023021090
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/15/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/23/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 2 DA
• Patient Sex: Male