The complainant was unable to provide the event/procedure date, therefore the first day of the month in which the event was reported was used ((b)(6) 2019).The complainant was unable to provide the suspect device upn and lot number as the device is part of a compliance kit; therefore, the expiration date, device manufacture dates, udi, and model number are unknown.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 a colonscopy procedure on an unknown date.According to the complainant, during the procedure, the seal biopsy valve was leaking.The procedure was completed with this device.There was no serious injury nor adverse patient effects reported as a result of this event.
|