|
Model Number M0068318261 |
Device Problem
Detachment Of Device Component (1104)
|
Patient Problem
Device Embedded In Tissue or Plaque (3165)
|
Event Date 03/06/2017 |
Event Type
Injury
|
Manufacturer Narrative
|
(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.
|
|
Event Description
|
It was reported to boston scientific corporation that a capio¿ slim was used during a anterior and posterior repair procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the capio carrier broke and detached.The procedure was completed with another capio¿ slim.The patient's condition at the conclusion of the procedure was reported to be stable.
|
|
Manufacturer Narrative
|
A visual examination of the returned capio slim revealed that the cage was damaged and the carrier was broken.The broken section of the carrier was not returned.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 review and analysis of all available information fails to indicate a root cause or probable root cause.Therefore, the root cause of this complaint is undeterminable.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label. .
|
|
Event Description
|
It was reported to boston scientific corporation that a capio¿ slim was used during a anterior and posterior repair procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the capio carrier broke and detached.The procedure was completed with another capio¿ slim.The patient's condition at the conclusion of the procedure was reported to be stable.
|
|
Search Alerts/Recalls
|
|
|