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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP RESECTOSCOPE CAUTERY LOOP; ELECTROCAUTERY LOOP

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BOSTON SCIENTIFIC CORP RESECTOSCOPE CAUTERY LOOP; ELECTROCAUTERY LOOP Back to Search Results
Model Number 880-213
Device Problems Break (1069); Device Inoperable (1663)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Known Impact Or Consequence To Patient (2692)
Event Date 05/01/2015
Event Type  malfunction  
Event Description
Doctor was beginning a tur of a bladder tumor and the resectoscope cutting loop was not working; it wasn't completely cutting through the tissue.The doctor took device out of bladder and found that the loop was broken.Doctor began again with a second loop and had the same problem.The second time, however, the entire loop broke off and was later retrieved from the bladder.A third loop was opened but because of the patient's lack of muscle relaxation, doctor opted to complete the procedure using a cup biopsy forcep and bugby electrode.The manufacturer was contacted and a complaint reported.Cautery settings at the time were 180 purce cut, 85 coag.Our hospital's bio med technician took this machine out of service for evaluation.There was a similar situation with the resectoscope cutting loop in another case earlier in the week.Our hospital's bio med tech could not find anything out of the ordinary regarding the loops.Manufacturer boston scientific was notified of the issue with the loops.We have three photographs available pertaining to the incident if med sun would like to see those.
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manufacturer response for resectoscope cutting loop, resectoscope cautery loop (per site reporter).
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boston scientific was made aware of the second incident right after it happened.The company has not provided any formal response since that day but they are generally very responsive.
 
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Brand Name
RESECTOSCOPE CAUTERY LOOP
Type of Device
ELECTROCAUTERY LOOP
Manufacturer (Section D)
BOSTON SCIENTIFIC CORP
300 boston scientific way
marlborough MA 01752
MDR Report Key4790396
MDR Text Key5813426
Report Number4790396
Device Sequence Number1
Product Code HIM
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Invalid Data
Type of Report Initial
Report Date 05/06/2015
3 Devices were Involved in the Event: 1   2   3  
2 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model Number880-213
Device Catalogue Number880-213
Device Lot Number0115006
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/02/2015
Was the Report Sent to FDA? Yes
Event Location Hospital
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/06/2015
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CAUTERY MACHINE WAS ALSO BEING USED BUT DIDN'T; NO OTHER THERAPIES; FORCE FX, CLINICAL ENGINEERING #827388.; CONTRIBUTE.CAUTERY MACHINE USED WAS A VALLEYLAN
Patient Age57 YR
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