Model Number 170051 |
Device Problems
Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923); Human-Device Interface Problem (2949)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
|
Event Date 06/25/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
Occupation: health professional (hpro).If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
According to the reporter, when the device was being applied to the jejunum during the sewing of the gastrojejunostomy on a laparoscopic roux en y gastric bypass, the device was difficult to unload at one point.The needle disengaged completely from the device but was still in the small bowel with the strand of suture attached, so it was visible the entire time.A new reload was used to complete the case.There was no patient injury.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
Post market vigilance (pmv) led an evaluation of a foil packaging and retainers of one device.Only foil packages and retainers were returned.Visual inspection found no abnormalities that would have caused or contributed to the reported condition.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all medtronic quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|