MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST STAPLER 45

Model Number 470298-11

Device Problem Device Issue (2379)

Patient Problem Failure to Anastomose (1028)

Event Date 04/02/2018

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, isi has not determined the root cause for the alleged post-operative complication experienced by the patient. If additional information is received a follow-up mdr will be submitted to the fda. The site¿s system logs with a procedure date of (b)(6) 2018 were reviewed. The system logs reveal that four stapler firings were completed using three green stapler 45 reloads and one white stapler 45 reload. However, during the third stapler firing using a green reload, there were 24 incomplete clamps in 25 attempts. The stapler 45 user manual instructs the following: "if clamping does not complete on the second attempt" to "reposition the stapler: tap the associated blue pedal once to unclamp. Reposition the stapler 45 to either grasp thinner tissue or to reduce the amount of tissue in the jaws. Then press and hold the associated blue pedal to clamp. " based on the information provided at this time, this complaint is being reported due to the following conclusion: after undergoing a da vinci-assisted lar procedure, the patient experienced an anastomotic leak. The surgeon alleged that the post-operative leak might have been caused by the stapler 45 instrument. However, at this time, the root cause of the post-operative complication is unknown.

Event Description

It was reported that after undergoing a da vinci-assisted low anterior resection (lar) procedure, the patient experienced an anastomotic leak. The surgeon claimed that a da vinci stapler instrument might have caused the post-operative complication. On 30-apr-2018, intuitive surgical inc. (isi) contacted the isi clinical sales representative (csr) and obtained the following information regarding the reported event: the csr was present during the case. He did not know if the procedure was recorded on video. At one point, the surgeon attempted multiple clamps that reached 97-99% but would not reach 100%. The surgeon kept "revving" and re-clamping the stapler instrument until finally achieving 100%. The csr described the patient as being "big" in terms of height. There were no reports of tissue bunching or tissue tension when firing the stapler instrument. He did not believe the rectum tissue was abnormally thick. The procedure was completed robotically. A circular stapler instrument was used during the case. On an unspecified date post-operatively, the patient was found to have an anastomotic leak where the stapler 45 instrument was used. According to the csr, the surgeon believes the tissue might have been damaged due to the multiple attempts to clamp on the tissue. The patient underwent another surgical procedure to repair the anastomotic leak. He did not know the current status of the patient.

• Brand Name: ENDOWRIST
• Type of Device: STAPLER 45
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 950 kifer road; sunnyvale CA 94086
• Manufacturer Contact: tabitha reed ; 950 kifer road; sunnyvale, CA 94086 ; 4085232100
• MDR Report Key: 7487244
• MDR Text Key: 107378731
• Report Number: 2955842-2018-10177
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 470298-11
• Device Lot Number: T10180125 0002
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 05/04/2018 Patient Sequence Number: 1

Treatment

DA VINCI INSTRUMENTS AND ACCESSORIES