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Catalog Number 7209931 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problems
Contusion (1787); Erythema (1840); Inflammation (1932)
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Event Date 11/01/2011 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6).(b)(4).
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Event Description
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It was reported per a literature review that during an evh procedure, co2 infiltration occurred through the deep inguinal ring and into the scrotum leading to acute scrotal enlargement.Due to the risk of impediment of vascular blood supply and necrosis, endoscopic vein harvesting was withdrawn, and the vein was harvested by using the bridging technique.Postoperatively, severe contusion, inflammation, and erythematous vesicular eruption resulted in a lengthened hospital stay.The patient was followed-up postoperatively on weeks 6 and 12, and no complications were noted.
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Manufacturer Narrative
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No additional relevant clinical supporting details were made available, thus a thorough medical assessment could not be performed by our clinical investigation team.The reported device was not made available to the designated complaint unit for evaluation, thus a visual inspection and functional testing could not be performed.The serial number of the devices used was not identified and thus a review of manufacturing records could not be conducted.A review of the complaint history record for the 400 insufflator, p/n 7209931, found no similar events in the 12 months prior to the journal publication date.The operations and service manual (p/n 1061349) for the smith & nephew 400 insufflator was reviewed and identifies the following indications and contraindications related to the proper use of the device relevant to the complaint event:the smith & nephew 400 insufflator is indicated for use for gas distension of the abdomen for diagnostic and/or operative laparoscopy.The smith & nephew 400 insufflator should be used only for laparoscopic procedures and should not be used for any other treatments.The use of the 400 insufflator is contraindicated for use in the procedure performed on this patient.Therefore, the use of the 400 insufflator for this particular procedure is considered to be off label.
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Search Alerts/Recalls
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