[7952048]
Event description: as we were informed by the distributor, the end of the draw wire near the hinge joint broke 30 minutes after start of a laparoscopic abdominal hysterectomy. There was no pt injury reported. The instrument in question was thoroughly checked by general mgr, senior surgical instrument engineer and quality mgmt representative: the instrument was manufactured with work order in a lot of 10 pcs. In 11/04 and delivered to the distributor on november 25th, 2004. We are able to trace back delivery until july 4th, 2002. Since then we have delivered a lot of pcs to the distributor without receiving a complaint. The production documents prove that the instrument was manufactured in accordance with the given production specifications and that no material defect or defect in manufacturing caused the problem. The instrument was inspected visually and we noticed that the shanks of the handle are extensively bent. [see scanned pages]. As requested by the hosp, we checked the instrument as to its completeness, whether any parts are missing and might probably have fallen inside the pt. We are able to confirm that no parts are missing. Conclusion: based on above findings, we assume that the draw wire broke because too much force (overstressing) was used via the handle. Since this evaluation indicates no defect of mateiral, no defect in design or any defect in manufacturing, we feel that no corrective measure is to be taken on our part. The user of the instrument should be informed that not too much force should be applied to the handle. This incident is classified as being not security relevant as per the guideline of the european union; and is also not subject to be reported since we had no info that pt injury was implicated.
Patient Sequence No: 1, Text Type: N, H10