RESECTOSCOPE CAUTERY LOOP 880-213

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-06 for RESECTOSCOPE CAUTERY LOOP 880-213 manufactured by Boston Scientific Corp.

Event Text Entries

[5813426] 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. ======================manufacturer response for resectoscope cutting loop, resectoscope cautery loop (per site reporter). ======================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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4790396
• MDR Report Key: 4790396
• Date Received: 2015-05-06
• Date of Report: 2015-05-06
• Date of Event: 2015-05-01
• Report Date: 2015-05-06
• Date Added to Maude: 2015-05-22
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: RESECTOSCOPE CAUTERY LOOP
• Generic Name: ELECTROCAUTERY LOOP
• Product Code: HIM
• Date Received: 2015-05-06
• Returned To Mfg: 2015-05-02
• Model Number: 880-213
• Catalog Number: 880-213
• Lot Number: 0115006
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: R
• Device Age: 1 DAY
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BOSTON SCIENTIFIC CORP
• Manufacturer Address: 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752

Device Sequence Number: 2

• Brand Name: RESECTOSCOPE CAUTERY LOOP
• Generic Name: ELECTROCAUTERY LOOP
• Product Code: HIM
• Date Received: 2015-05-06
• Model Number: 880-213
• Catalog Number: 880-213
• Lot Number: 0115006
• ID Number: *
• Device Availability: R
• Device Age: 1 DA
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: BOSTON SCIENTIFIC CORP
• Manufacturer Address: 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752

Device Sequence Number: 3

• Brand Name: *
• Generic Name: *
• Product Code: ---
• Date Received: 2015-05-06
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Age: *
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: BOSTON SCIENTIFIC CORP
• Manufacturer Address: 300 BOSTON SCIENTIFIC WAY MARLBOROUGH 01752 * 01752

Patients

Patient Number	Treatment	Outcome	Date
1	0		2015-05-06
2	0		2015-05-06