The user facility claimed that "scalpel plate placed at the level of the left thigh.Patient in supine position, after insufflation, 2 trocars in place, and the surgeon decides to remove an adhesion.Activation of the bipolar forceps: immediate stop because of noise and visualization of the burn located above the pubis / lower abdomen (patient's left side).Visual inspection of the operating field and the patient: no additional burns observed on the patient." the treatment was continued with other products and completed with an unspecified delay.
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The working element active mono/bipo: part no.8653204, lot no.1378013, was manufactured on 09/apr/2018.According to the production record, no abnormalities have been noted.As soon as the investigations are completed, a follow-up report will be submitted.
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The entire system, apart from the used electrode(s), was returned for investigation.They were investigated in the responsible department.It was determined that the system has no defects according to the test instructions.The insulation and continuity tests are in compliance.The instruments only shows typical signs of use.However, the error pattern of a noise and a burn indicates an electrical arcing together with a burn-through of the cable and/or the electrode.As a result, the replacement of the cable/electrode is necessary, which was also described by the user as remedial action.However, a defective cable or electrode was not returned by the user.Furthermore, no settings of the hf generator were indicated, which is usually the cause of the error pattern.The working element active mono/bipo 865320, batch # 1378013 was manufactured on 09/apr/2018.The batch consisted of 5 pieces.No issues were identified during production, no further complaints were received from the reported batch.The ifu ga-d 349 / en-us / 2015-02 v6.0 / eco 2014-0506 contains several descriptions regarding the proper handling and correct settings during hf application in sections 8 checks, 7.1.7 inserting working insert (7) with panoview telescope (8) into the resectoscope sheath, 7.1.10 inserting working element (9) (10) into the resectoscope sheath, 7.2.4 irrigation fluid and in section 7.2.5 hf-application (monopolar/bipolar).The subject issue of noise and burn of the devices is present in the risk management file b6 - reusable optical working inserts, rev.04.The overall probability of occurrence for this issue remains at previously defined levels and overall risk of the device remains in the acceptable category.
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