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

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.

• 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 Key: 4790396
• MDR Text Key: 5813426
• Report Number: 4790396
• Device Sequence Number: 1
• Product Code: HIM
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Number: 880-213
• Device Catalogue Number: 880-213
• Device Lot Number: 0115006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2015
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/06/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• 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 Age: 57 YR