MEDLINE RENEWAL REPROCESED ARTHROSCOPIC SHAVER
Received Nov 8, 2016
Report 3032391-2016-00002 · MDR key 6087893
Device
Generic name
Arthroscopic Shaver
Manufacturer
Medline RenewalModel number
AR-8350DSCatalog number
AR-8350DS
Lot number
238060
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Post Operative Wound Infection
- Post Operative Wound Infection
Narrative
Additional Manufacturer Narrative
(B)(4) RECEIVED A REPORT FROM A USER FACILITY THAT A PATIENT DEVELOPED A POST-OPERATIVE INFECTION WHERE A (B)(4) REPROCESSED ARTHROSOCPIC SHAVER WAS USED. OTHER DEVICES WERE ALSO USED DURING THE SURGICAL PROCEDURE. THE USER FACILITY STATED THAT GATHERING STERILIZATION INFORMATION FROM VENDORS WHO CLEAN/STERILIZE DEVICES OUTSIDE OF THEIR FACILITY IS PART OF THEIR ROUTINE INVESTIGATION, AND THAT THERE IS NO WAY TO DETERMINE IF THE REPROCESSED ARTHROSCOPIC SHAVER CAUSED OR CONTRIBUTED TO THE INFECTION. A REVIEW OF THE MANUFACTURING DOCUMENTATION AND THE STERILIZATION CYCLE RECORDS WAS PERFORMED, AND ALL CLEANING, PROCESSING AND STERILIZATION REQUIREMENTS WERE MET. THERE HAVE BEEN NO OTHER SIMILAR ISSUES OR CONCERNS REPORTED TO US FOR LOTS THAT WERE STERILIZED IN THE SAME STERILIZATION CYCLE. WE HAVE NO INFORMATION TO SUGGEST THE DEVICES CAUSED OR CONTRIBUTED TO THE REPORTED INFECTION. HOWEVER, IN AN ABUNDANCE OF CAUTION, DUE TO THE REPORTED INCIDENT THIS MEDWATCH IS BEING FILED. THIS MEDWATCH REPORT WAS ORIGINALLY SUBMITTED ON 02/16/2016, HOWEVER DUE TO AN INTERNAL ERROR, THIS REPORT WAS SUBMITTED THROUGH THE ESG TEST ACCOUNT INSTEAD OF THE ESG PRODUCTION ACCOUNT. CONSEQUENTLY, CDRH DID NOT RECEIVE THIS REPORT WITHIN THE 30 DAY TIMEFRAME. THEREFORE, THIS MEDWATCH REPORT NOW REFLECTS TODAY'S DATE WHICH CORRESPONDS WITH THE FILE TRANSMISSION THROUGH THE ESG PRODUCTION ACCOUNT. DEVICE WAS NOT SAVED FOR EVALUATION.
Description of Event or Problem
(B)(4) RECEIVED A REPORT FROM A USER FACILITY THAT A PATIENT DEVELOPED A POST-OPERATIVE INFECTION WHERE A MEDLINE RENEWAL REPROCESSED ARTHROSOCPIC SHAVER WAS USED. OTHER DEVICES WERE ALSO USED DURING THE SURGICAL PROCEDURE. THE USER FACILITY STATED THAT GATHERING STERILIZATION INFORMATION FROM VENDORS WHO CLEAN/STERILIZE DEVICES OUTSIDE OF THEIR FACILITY IS PART OF THEIR ROUTINE INVESTIGATION, AND THAT THERE IS NO WAY TO DETERMINE IF THE REPROCESSED ARTHROSCOPIC SHAVER CAUSED OR CONTRIBUTED TO THE INFECTION.