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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER VALLEYLAB ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)

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COVIDIEN MFG DC BOULDER VALLEYLAB ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES) Back to Search Results
Model Number E1562
Device Problem Break (1069)
Patient Problem Blood Loss (2597)
Event Date 03/08/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The return of the incident sample has been requested. To date, it has not been received for evaluation. Additional questions in regard to the incident have been asked. If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.
 
Event Description
The customer reported that the loop electrode snapped at edge. There was a fair amount of tissue loss. Additionally, there was more than 500cc of bleeding but no transfusion was needed. The area was sutured. The patient is stable.
 
Manufacturer Narrative
One e1562 loop electrode was received for evaluation. Visual inspection found the wire loop to have broken. The customer reported a forcefxc generator with coag output at 70 was used during the procedure. According to the instructions for use, covidien recommends a maximum power setting of 55w cut for this type of electrode. This type of electrode should never be used in the coagulation mode. The investigation identified the root cause of the reported event to be user misuse by exceeding recommended power setting and using the device in the coagulation mode. The ifu states loop electrodes are not designed for use in the coagulation mode. Do not activate the generator in coag while using a loop electrode. Loop breakage may result. Exceeding maximum power setting may result in patient injury or product damage. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The customer reported that the loop electrode snapped at edge during a leep procedure. A forcefxc generator with coag output at 70. There was a fair amount of tissue loss. Additionally, there was more than 500 cc of bleeding but no transfusion was needed. The area was sutured. The patient is stable.
 
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Brand NameVALLEYLAB
Type of DeviceELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)
Manufacturer (Section D)
COVIDIEN MFG DC BOULDER
5920 longbow dr
boulder CO 80301 3299
Manufacturer (Section G)
COVIDIEN MFG DC BOULDER
5920 longbow dr
boulder CO 80301 3299
Manufacturer Contact
sharon murphy
5920 longbow drive
boulder,co, CO 80301
2034925267
MDR Report Key6433383
MDR Text Key105135429
Report Number1717344-2017-05144
Device Sequence Number1
Product Code HGI
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K931338
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/01/2020
Device Model NumberE1562
Device Catalogue NumberE1562
Device Lot Number0816BX
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/05/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/09/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/24/2017 Patient Sequence Number: 1
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