MAUDE Adverse Event Report: RECON COMPANY, LLC THUMB FORCEPS; FORCEPS, GENERAL & PLASTIC SURGERY

Model Number 10-884

Device Problems Device Reprocessing Problem (1091); Inadequate Instructions for Healthcare Professional (1319); Product Quality Problem (1506)

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

Event Date 05/19/2021

Event Type  malfunction  

Event Description

"no date available for ifu and no company direct contact info.Old, old term ifu incomplete and old.This is not a standard cycle and this is a stainless steel instrument and lumens why can't it be ran at 4 mins prevac at chemical indications for steam sterilization or biological indications are on the market in usa for 5 min cycle.What edition? wrapped with what, why not a patch; vacuum typically refers to sterilization phase not dry.For a problem with a medical device, including: any health-related test, tool, or piece of equipment.How was this approved?".

• Brand Name: THUMB FORCEPS
• Type of Device: FORCEPS, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): RECON COMPANY, LLC; 510 north street; auburn IN 46706
• MDR Report Key: 12016419
• MDR Text Key: 257248611
• Report Number: MW5101932
• Device Sequence Number: 1
• Product Code: GEN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial

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: No Information
• Device Model Number: 10-884
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/16/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other