MAUDE Adverse Event Report: ALIMED, INC. GOMCO CIRCUMCISION CLAMP; CLAMP, CIRCUMCISION

Catalog Number 98CLA6-1

Device Problems Material Discolored (1170); Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 03/02/2023

Event Type  Other  

Event Description

This is a fyi issue that rose from a the joint commission (tjc) survey finding.The recommendation received from tjc is to file a report with fda as no recall has been issued and the problem is not specific to one vendor.Tjc believes there is a problem with the integrity of the material being used to manufacture the instruments.Situation: discoloration has been found in the threading of the medical device in both new and used gomcos.History: in a previous tjc survey, it was cited due to gomco clamps being pre-assembled during the sterilization.This process did not align with the medical device ifu.All affected parties have been made aware, and the process has been updated to reflect disassembly before sterilization.Background: during a recent infection prevention control rounding, an infection control specialist opened a sterile gomco and used an alcohol wipe to clean the discolored threading of the gomco.Some remnants were smeared onto the wipe.Spd (sterile processing department) was notified, and our team went to the area and pulled all 1.1 and 1.3 size gomcos out of circulation to treat them with surgistain.Surgistain: a safe chemical used on instrumentation to remove rust, stain, pitting, hard water, and mineral deposits.Spd found that the discoloration in the threading was still apparent after surgistain treatment.Spd took the instrument to our 3rd party instrument repair specialist for further insight.He explains that the material used on the gomcos is plated with chrome, and underneath lies brass.Brass tarnishes over time because its metal components are exposed to oxygen¿a natural process.This process can take a few days to a week; however, the repetition of screwing the gomco knut onto the threading speeds up oxidation.Spd reached out to alimed requesting a customer letter stating that the discoloration results from oxidation and will not affect patient care.Assessment: the gomco is a medical two device; however, the threading does not come in contact with the patient skin.The newborn nursery area reported no patient safety issues in the past alimed discontinued the item due to low-demand item and has nothing to do with the discoloration.No history of a recall through alimed.Resolution: spd also had disposable options sent to providers to review as a secondary option in case they want to try a one-time-use alternative.Gomco product information: alimed ref #: (b)(4).

• Brand Name: GOMCO CIRCUMCISION CLAMP
• Type of Device: CLAMP, CIRCUMCISION
• Manufacturer (Section D): ALIMED, INC.; 297 high street; dedham MA 02026
• MDR Report Key: 16785783
• MDR Text Key: 313741856
• Report Number: 16785783
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/02/2023

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?: No
• Device Catalogue Number: 98CLA6-1
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/02/2023
• Date Report to Manufacturer: 04/21/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/21/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1