MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC CONTOUR; STAPLER, SURGICAL

Catalog Number CS40B

Device Problem Misfire (2532)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/24/2016

Event Type  malfunction  

Event Description

The conture staple device did not fire smoothly per the surgeon.The stapler was removed from the field and replaced with a new one - the stapling was completed by the surgeon as desired.The description of how the stapler was being used are contained below: "at this time, we turned our attention to the rectosigmoid resection given the tumor involvement.Again, we had developed the retro rectal space and the pararectal spaces and we identified a segment of viable colon which was not involved with tumor and the mesentery appeared to be preserved.We identified the superior rectal artery and was ligated given the proximity to the tumor involvement.We identified a segment of viable colon not involved with cancer.This was transected with ila 100 staplers.Subsequently, the mesentery was then clamped and ligated sequentially with ligasure device into the retrorectal space, which was clear.We continued to mobilize the mass of the sacrum medially from the left and right pelvic sidewall by further opening the paravesical spaces.At this time, the involved sigmoid, colon, and rectum were mobilized cephalad.Approximately 7 cm of colon was affected from cancer.This was mobilized cephalad.We then found an area approximately 2 cm below the tumor which appear healthy, viable, and not to be involved with any malignant cells.At this time, we took the contour stapler with a blue load, fired across the rectum in this area and passed off the rectosigmoid for final pathology.At this time, prior to completing our anastomosis, we ligated several points of bleeding in the pelvis.We then began to complete our anastomosis.Turning attention to proximal limb of the sigmoid colon which was amputated, we placed a pursestring device around this, fired and then opened the limb of colon.Utilizing the eea sizers, we found her to accommodate 31 size anvil.This was placed within that limb of the colon and the colon was closed with a pursestring.Attention was then turned down to the hartman's pouch.We used the eea stapler and that was passed to the top of the pouch and the spike was deployed.At this point we had to resect more distal colon because the eea stapler made a small defect in the distal limb.The rectum was further dissected and a new contour stapler with a blue load, fired across the rectum in this area.We again used the eea stapler and that was passed to the top of the pouch and the spike was deployed.Utilizing 2 full turns of the stapler at this time, was attached to the anvil which had been placed in the descending colon.Again, utilizing full turns of the stapler, this was slowly brought back together and joined.Excellent hemostasis was noted.We took care to ensure that there were no twists under the colon and the colon was in the normal position.Anastomosis was approximately 5 cm above the anal verge with no tension.At this time, the staple was fired.The stapler was turned 1 full turn, turned 90 degrees and then removed from the patient's rectum.The rectal donuts were intact.Irrigant was placed in the pelvis and no evidence of leak was noted with a bubble test.The test was repeated three times with no evidence of leak.At this point, the fluid was removed.In addition, we placed fluid with blue dye into the rectum to confirm that the anastomosis was intact.Again, there was no evidence of leak." manufacturer response for ethicon contour stapler, ethicon contour stapler (per site reporter): operating room contacted ethicon.The original intended procedures were: preoperative diagnosis: metastatic endometrial adenocarcinoma of the endometrium.Postoperative diagnosis: same versus endometrial cancer and second primary ovarian cancer.Optimally cytoreduced no residual disease.Name of operation: examination under anesthesia.Exploratory laparotomy.Retroperitoneal dissection.Bilateral ureterolysis.Bilateral salpingo-oophorectomy.Modified radical hysterectomy.Gastrocolic omentectomy.Resection of diaphragmatic nodule.Rectosigmoid resection with anastomosis.Appendectomy.Protective loop ileostomy.Ip port placement.

• Brand Name: CONTOUR
• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC; 4545 creek rd.; cincinnati OH 45242
• MDR Report Key: 5811638
• MDR Text Key: 50080541
• Report Number: 5811638
• Device Sequence Number: 1
• Product Code: GAG
• 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: Other
• Type of Report: Initial
• Report Date: 07/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: CS40B
• Device Lot Number: M9382N
• Other Device ID Number: CURVED CUTTER STAPLER
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/12/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 07/12/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: THE STAPLE WAS BEING USED IN THE CONTEXT OF A SURG
• Patient Age: 31 YR