MAUDE Adverse Event Report: CIRCLAMP WITH BELL; CLAMP, CIRCUMCISION

Lot Number 2022101001

Device Problems Contamination (1120); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 02/14/2023

Event Type  malfunction  

Event Description

Several sterile circlamps were opened ( both new and reprocessed) and found to have a defects.The sterile items were found with pitting and rust appearing residue upon inspection.The round screw area appeared to be dirty upon opening package.Upon discovery of this issue the circlamps have all been pulled from areas that use them in our facility.Medline representative was also notified of the finding and pictures were sent to the rep.Alternative products were ordered to be received the following day (2/16/2023).Reference reports: mw5115045, mw5115047.

Event Description

Additional information received on 02/22/2023 for report mw5115046.

Event Description

Additional information received on 02/22/2023 for report mw5115046.

• Brand Name: CIRCLAMP WITH BELL
• Type of Device: CLAMP, CIRCUMCISION
• MDR Report Key: 16400903
• MDR Text Key: 309956595
• Report Number: MW5115046
• Device Sequence Number: 1
• Product Code: HFX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 02/16/2023

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
• Device Operator: Health Professional
• Device Lot Number: 2022101001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/16/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/22/2023
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic
• Patient Race: White