MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. XI SUREFORM STAPLER 60MM; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Model Number 480460

Device Problems Failure to Form Staple (2579); Failure to Cut (2587); Firing Problem (4011)

Patient Problem Obstruction/Occlusion (2422)

Event Date 07/07/2021

Event Type  Injury  

Event Description

Patient underwent robotic-assisted right hemicolectomy with intracorporeal anastomosis.The right colon was mobilized medially to laterally before the omentum was taken off the transverse colon to facilitate mobilization of the hepatic flexure.The vessel sealer was used to take the mesentery up to the proximal and distal transection points, the blood supply to which was confirmed using 3mls of icg and firefly.Sureform 60 blue loads were taken across the small bowel and transverse colon, with the specimen subsequently placed over the liver.An intra-corporeal iso-peristaltic ileum to transverse colon anastomosis was then undertaken along a measured length of 8cm of bowel using the sureform 60 blue stapler placed through an opposing enterotomy and colotomy.A running 3-0 v-loc was used to close the enterocolotomy in two layers.The anastomosis was healthy, pink, under no tension, appropriately orientated, and with great blood supply confirmed with firefly.The procedure was performed as intended with no identified issues noted during the procedure or immediately postoperatively.Six days later, the patient was returned to the or for an intestinal obstruction.An enterotomy and colotomy were made in the small and large bowel distal and proximal to the anastomosis respectively to re-do the anastomosis with a single fire of the gia 80 blue and ta 90 green loads.The mesentery of the original anastomosis was taken with the ligasure and the specimen taken for inspection.There was evidence of device failure with two rows of staples on small bowel side but of limited length.No common channel or evidence of complete staple firing and cutting sequence.Full thickness large bowel still present and submucosa/muscularis of small bowel present.No mucosal lifting or ability to pop through mucosa to create common channel to suggest submucosal placement of stapler.Ultimately identified apparent device failure with partial firing of stapler but no cutting during initial procedure with perhaps exception towards crutch of stapler at end of enterotomies causing complete small bowel obstruction.

• Brand Name: XI SUREFORM STAPLER 60MM
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 12134014
• MDR Text Key: 260515146
• Report Number: 12134014
• Device Sequence Number: 1
• Product Code: NAY
• 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: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480460
• Device Lot Number: T90210122-0024
• 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: 07/06/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 23725 DA