MAUDE Adverse Event Report: COVIDIEN LP 15X12MM DSP TNG LLETZ LOOP; ES ACCESSORY

Model Number E1560

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Covidien reference#: (b)(4).Date of initial report: 11/2/2016.The incident device has been received and is under evaluation.When the device evaluation is complete a follow-up report will be submitted.

Event Description

The customer reported that a female patient who was having colposcopy + removal of mirena iud, lletz procedure and re-insertion of mirena.During the first pass of the product for the loop biopsy the theatre manager described the loop as shorting out and reported that a spark and a noise emitted from the distal end of the tungsten loop.Upon the surgeon's examination of the product, the loop had approximately 6-8mm of wire missing.The surgeon spent approximately 5 mins looking for the missing section of wire both visually and via tactile touch but could not find the wire.The loop was replaced and the case continued with a second cervical pass without further complication.There was no additional bleeding or pain reported after the incident.The generator settings were cut: 120w, coag: 60w.The patient was x-rayed and the result was negative.No foreign bodies/metal fragments were present.The patient is doing well and has not required any additional follow-up as a consequence of this incident.Isplayed a sticker stated the last service was 2011.The unit had an electrosurgery check by the hospital biomeds within the last 12 mths, for an electrical safety check only.It appears that this unit has not had a calibration and service for some time,.

Manufacturer Narrative

(b)(4).Evaluation of the incident device confirmed the reported event.Visual inspection found a section of the tungsten loop of the electrode to be missing.Both ends of the loop were still attached to the body of the electrode.One of the attached sections was bent.The electrode showed signs of charring where the tungsten loop attaches to the body of the electrode.The customer reported that the generator was set 120w in the cut mode and 60w in coag mode.These setting exceed the maximum recommended power settings.This device should not be used in coag mode.The instructions for use state that the maximum power setting for a loop electrode in the pure cut or blend mode should 55w.The ifu also 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.

• Brand Name: 15X12MM DSP TNG LLETZ LOOP
• Type of Device: ES ACCESSORY
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow drive; boulder CO 80301
• Manufacturer Contact: sharon murphy ; 5920 longbow drive; boulder, CO 80301 ; 2034925267
• MDR Report Key: 6072763
• MDR Text Key: 58978077
• Report Number: 1717344-2016-01007
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K931338
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E1560
• Device Catalogue Number: E1560
• Device Lot Number: 0115DX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/20/2016
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: COVIDIEN FORCETRIAD SN (B)(4)
• Patient Outcome(s): Other
• Patient Age: 29 YR
• Patient Weight: 88