The exact age of the patient is unknown.However, it was reported the patient was over 18 years.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.Problem of needle detachment.The complainant indicated that the device is disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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It was reported to boston scientific corporation that a capio¿ slim was used during a cystocele repair with sacrospinous ligament fixation procedure.According to the complainant, during procedure, the needle detached from the suture after deployment through the sacrospinous ligament.X-ray done to patient but the needle was not located.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be unharmed.
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