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

Model Number 60MM 2.6 WHITE

Device Problems Positioning Failure (1158); Defective Component (2292); Misfire (2532)

Patient Problem Failure to Anastomose (1028)

Event Date 08/30/2017

Event Type  malfunction  

Event Description

While performing a laparoscopic roux en y gastric bypass, the surgeon used an ethicon staple reload in his laparoscopic instrument.It was discovered that the stapler reload was defective and did not have 3 rows out of 6 loaded with staples and therefore did not staple properly.They did not deploy staples down the one side of the cutter.The area with the failed staple deployment had to be hand sewn by the surgeon.Ethicon rep was notified.The remaining boxes with identical lot numbers were removed from the core.Notes from the operative report:."initially, the omentum was divided in the left paramedian plane using the harmonic scalpel up to the level of the transverse colon.The colon was then elevated and the ligament of treitz was identified.The jejunum was measured to 100 cm and divided with an endo-gia stapler.The distal small bowel was then measured to 150 cm and the jejunojejunostomy was constructed between the 2 segments of small bowel to create the roux limb.At this point, i made my enterotomies and introduced a 60 mm white load and positioned it properly, and then when i advanced the drivers, the anterior wall separated without any apparent staple deployment.I inspected the posterior wall carefully.There were staples and the anastomosis appeared to be intact on the back side; however, as i mentioned, no staples were deployed anteriorly.Apparently there were 3 rows without any staples in the cartridge.The stapler and cartridge were reserved for forensic evaluation by the company.At this point, i had to close the anastomosis and i used the ligasure device with 3-0 vicryl.I started distally and sewed the anterior wall in a running fashion, incorporating closure of the common enterotomy.A second row was placed using 3-0 vicryl to imbricate the full-thickness inner layer of the anastomosis.The anastomosis appeared to be intact.At this point, i closed the mesenteric defect with the ligasure and 2-0 tevdek.".(towards the end of the case): "the roux limb was closed with an endo-gia stapling.Leak test was performed with methylene blue instilled through an ng tube.The gastrojejunostomy was intact.I then placed additional methylene blue through the ng tube and followed it down through the roux limb and through the jejunojejunostomy.There was no obvious leak through the jejunostomy, although i did not place it under pressure.At this point, the ng tube was removed."."the patient was awakened, extubated, and taken to the recovery room in stable condition." the surgeon listed as a complication: "the complication was one of equipment malfunction, endo-gia misfire.".

• Brand Name: ENDO-GIA
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN; 60 middletown ave; north haven CT 06473
• MDR Report Key: 7045524
• MDR Text Key: 92535462
• Report Number: 7045524
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2020
• Device Model Number: 60MM 2.6 WHITE
• Device Lot Number: P4RP440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/27/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/27/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/20/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 119