BOSTON SCIENTIFIC - MARLBOROUGH UPHOLD¿ LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number M0068318170 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/07/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation that an uphold¿ lite was used during a sacrospinous ligament (ssl) fixation procedure performed on (b)(6) 2017.According to the complainant, during the procedure, after multiple attempts to catch the needle with the capio cage, the cage broke such that it partially detached.The carrier was also noted to be broken.The broken section of the carrier was retrieved from the patient by a hand.The procedure was completed with another uphold¿ lite.The patient's condition at the conclusion of the procedure was reported to be stable.
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Manufacturer Narrative
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A visual examination of the returned uphold lite device revealed that the cage was lifted and bent.The carrier is not broken or detached.The mesh assembly was not returned for analysis.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.The investigation concluded that this complaint is associated with a product that meets the design and manufacture specifications but due to anatomical/procedural factors encountered during the procedure, performance of the device was limited.The most probable root cause classification is operational context.
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Event Description
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It was reported to boston scientific corporation that an uphold lite was used during a sacrospinous ligament (ssl) fixation procedure performed on (b)(6) 2017.According to the complainant, during the procedure, after multiple attempts to catch the needle with the capio cage, the cage broke such that it partially detached.The carrier was also noted to be broken.The broken section of the carrier was retrieved from the patient by a hand.The procedure was completed with another uphold lite.The patient's condition at the conclusion of the procedure was reported to be stable.
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