MAUDE Adverse Event Report: COVIDIEN LP ENDO GIA ULTRA; STAPLE, IMPLANTABLE

Model Number EGIAUSTND

Device Problem Component Missing (2306)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/29/2019

Event Type  malfunction  

Event Description

From staff: during a laparoscopic left lower lobectomy, a suction catheter was partially inserted into the left bronchial tube of the double lumen endotracheal tube to suction the air out of the lung and then removed.As it was filling back up during the surgery, it was reinserted to optimize surgical conditions.When it was time for the surgeon to deploy the stapler to transect the bronchus, the surgeon unknowingly stapled across the suction catheter.When it was time to begin ventilating the left lung again, an attempt was made to remove the catheter, but resistance was encountered.The attending anesthesiologist was notified, who then attempted to remove it.Then the surgeon was notified of the resistance.The surgeon performed a bronchoscopy through the tracheal lumen and then using force removed the suction catheter.It was determined the tip of the catheter was missing.They searched for it using the bronchoscope and also the laparoscope, but could not find any evidence of it remaining.It was suspected to be in the resected portion of lung, which pathology confirmed.The surgeon then resected another small portion of bronchus to ensure there was none in the staple line.There were no obvious adverse outcomes for this patient.From op report: when we went to reinflate the lung, the anesthesia team noted that a suction catheter they had placed during 1 lung ventilation was not freely mobile.The staple line looked entirely unremarkable, but i was concerned that perhaps this catheter had drifted further down into the lower lobe bronchus and had actually been contained within the staple line.At this point in time, i scrubbed out and more aggressively removed the catheter, which was in the bronchial lumen really without too much incident.We did note that the catheter appeared to be missing about 5-8 mm of its tip, however.Visualization through the thoracoscope of the bronchial stump again revealed it to be really unremarkable.I did not even see a defect here.I spoke with the attending pathologist on the phone, who opened the bronchial stump in the pathology department, and did identify that there was a piece of plastic, which corresponded identically with what we had felt to be missing.This was sent to the room and we confirmed that this was indeed what happened.I did a full bronchoscopic exam of the patient and there was no evidence of any retained foreign object within the airway and again we had excellent visualization of the chest throughout this process and there was no evidence of any retained foreign object within the space.While the bronchial stump appeared intact, i did wish to re-staple this and had enough length that i was quite able to easily place the covidien stapler again behind my original staple line and re-excise this completely.This was sent to pathology as a final bronchial margin specimen.The lung reinflated nicely.There was no evidence of any significant air leak.

• Brand Name: ENDO GIA ULTRA
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 8992342
• MDR Text Key: 157455951
• Report Number: 8992342
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EGIAUSTND
• Device Catalogue Number: EGIAUSTND
• Device Lot Number: P8K1313X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/24/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 12775 DA
• Patient Weight: 97