MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; PATIENT SIDE CART, 4-ARM

Model Number 380652-48

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 09/13/2021

Event Type  Injury  

Event Description

It was reported that after undergoing a da vinci-assisted low anterior resection procedure, the patient underwent two additional re-operations.Intuitive surgical, inc.(isi) contacted the surgeon and obtained the following additional information regarding the reported event: after undergoing a da vinci-assisted rectal procedure, on an unspecified date, the patient was identified to have free air in the abdomen allegedly due to suture failure.The cause of the suture failure was not provided.As a result, the patient underwent an initial re-operation.Due to gas retained in the abdomen, the patient underwent a second re-operation.After the second re-operation, the patient recovered.Both of the procedures were not robotic-assisted procedures.It is unknown how the anastomosis was created during the initial robotic procedure and what specifically leaked post-operatively.The surgeon confirmed that there was no malfunction of the da vinci system/instruments during the initial robotic procedure.The re-operations were secondary to the leak from a suture failure of the rectum.The surgeon stated there was no relationship between the da vinci system and the leak.

Manufacturer Narrative

Based on the current information provided by the surgeon, the root cause of the reported post-operative complication was determined to be suture failure.There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.System and stapler log reviews were completed for the procedure: stapler logs show that a sureform 60 stapler instrument (part number 480460-09, lot l91200415-0175) was installed once, using a blue reload.The firing was completed per the logs with no pauses for compression.There were no incomplete clamps by this instrument.A review of the site's system logs for the reported procedure shows that there were no related system errors to have occurred during the surgical procedure that would have likely caused or contributed to the reported complaint.No image or video clip for the reported event was submitted for review.A review of the site's complaint history was performed and no other complaints for this product/event were found.This complaint will be reportable due to the following conclusion: after undergoing a da vinci-assisted rectal procedure, the patient underwent two additional re-operations.The re-operations were performed as a result of a post-operative leak allegedly caused by a suture failure.Although the surgeon stated there was no relationship between the da vinci system and the leak, it is unknown if a da vinci product contributed to the reported issue.There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.

• Brand Name: DAVINCI XI
• Type of Device: PATIENT SIDE CART, 4-ARM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 12954465
• MDR Text Key: 287275720
• Report Number: 2955842-2021-11684
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380652-48
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/08/2021
• Initial Date FDA Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES