The complainant was unable to provide the suspect device lot number, as the device is part of a compliance kit; therefore, the expiration date, device manufacture dates are unknown.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
|
It was reported to boston scientific corporation that a seal biopsy valve was used during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the seal biopsy valve fell off and leaked.Another seal biopsy valve was used to complete the procedure.There were no patient complications as result of this event.
|