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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GYRUS ACMI, INC. CONTINUOUS FLOW INNER SHEATH; RESECTOSCOPE SHEATH
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GYRUS ACMI, INC. CONTINUOUS FLOW INNER SHEATH; RESECTOSCOPE SHEATH Back to Search Results
Catalog Number ERIS-CF25
Device Problem Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 11/24/2016
Event Type  malfunction  
Event Description
During a cystoscopy, a small plastic piece of the resectoscope had broken.The doctor reported that he/she was able to recover the small and large plastic pieces.While we can not be sure that 100% of the fragments were located, the doctor did a thorough search for a long period of time and needed to proceed with the procedure.The procedure continued without further complications and the patient was transferred to the recovery room in good condition.There were no complications.Per our sterile processing department this facility is following gyrus acmi's recommendations for cleaning and sterilizing.Our spd supervisor did post a note on the instructions for cleaning/sterilizing the devices for staff to pay extra attention to the integrity of all of the pieces.Http://www.Onesourcedocs.Com/member/show-document.Html?id=208551.
 
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Brand Name
CONTINUOUS FLOW INNER SHEATH
Type of Device
RESECTOSCOPE SHEATH
Manufacturer (Section D)
GYRUS ACMI, INC.
93 north pleasant st.
norwalk OH 44857
MDR Report Key6215654
MDR Text Key63640968
Report Number6215654
Device Sequence Number1
Product Code FJL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 12/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Physician
Device Catalogue NumberERIS-CF25
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/07/2016
Event Location Hospital
Date Report to Manufacturer12/07/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/30/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age73 YR
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