Model Number 720163-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Tissue Injury (4559)
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Event Date 07/06/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient was administered with local anesthesia for ams xp sling implant original surgery to treat incontinence.However, the physician dissected past the spongiosum and was too close to the urethra and did not want to place mesh too close to the dissected area.The physician decided to cancel the surgery.
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Manufacturer Narrative
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There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms are a known risk associated with implant of these devices as indicated in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
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Event Description
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It was reported that the patient was administered with local anesthesia for ams xp sling implant original surgery to treat incontinence.However, the physician dissected past the spongiosum and was too close to the urethra and did not want to place mesh too close to the dissected area.The physician decided to cancel the surgery.
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Search Alerts/Recalls
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