Country of complaint: (b)(6).It was reported that the legs of the clip crossed, this caused a tear in the skin.A disposable clip had to be used to close the wound and stop the bleeding.Components in use listed as concomitant devices are: pl569t / ligating clips m/l 12 box, pl510r / handle f/pl506r & pl508r.
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Investigation: after the receipt of the products, the measurement of the devices was carried out by the quality assurance of the production department.Shaft pl538r: target current: *01* 67.80mm 67.78mm ok, *02* 10mm gauge ok, *03* 3.85mm 4.00mm ok, *04* 7.00mm 6.85mm ok, *05* 6.50mm 6.6mm ok.Inner rod pl538801: -out of service, -bent, -running rough, -slider sheet of the magazine is not pulled back-thus no feed of the magazine.Inner pipe pl538802: -out of service.Handle pl510r: -out of service.Magazine pl569t: -no clips remaining in the magazine.-"nose' broken off.Batch history review: the product does not require batch management; a review of the device quality and manufacturing history records is not possible.Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most probably related to an insufficient maintenance of the device.Rational: no capa is necessary.
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