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

Model Number 470298-11

Device Problem Use of Device Problem (1670)

Patient Problem Injury (2348)

Event Date 03/24/2017

Event Type  Injury  

Manufacturer Narrative

Intuitive surgical, inc. (isi) has received the stapler 45 instrument involved with this complaint and completed investigations. Failure analysis investigation confirmed the customer reported complaint. The broken srk piece was observed to be stuck in housing port 1. The broken piece was removed and the instrument installed on an in-house da vinci surgical system passed initialization testing. The instrument also clamped and fired. Failure analysis investigations also found during review of the site's system logs that during the surgery the site experienced clamping and unclamping failures. The unclamp failure occurred during the instrument second installation of the instrument, after an incomplete clamp. The clamp was 75% complete and the unclamp that followed failed at 31% completion. There was no hardware damage found on the instrument that may have contributed the unclamp failure. In-house testing did not replicate the unclamp failure. The srk was also returned for evaluation. The srk was found to be twisted and completely broken off. Isi has issued a customer notification with instructions on proper usage of the srk. Isi has conducted a device history record (dhr) review for this device and did not find any non-conformances that were related to the reported event. Based on the information provided, this complaint is being reported due to the following conclusion: during a da vinci assisted lar procedure, the stapler 45 instrument would not unclamp from the patient's tissue, requiring use of the srk. The srk broke during its use. Unable to release the instrument jaw from the patient's tissue, the surgeon made the decision to create an abdominal incision to remove the instrument's jaw. While there was no report of any patient harm, adverse outcome or injury to the patient, recurrence of the reported failure mode could likely cause or contribute to an adverse event. It is unknown what caused the unclamping issue.

Event Description

It was reported that during a da vinci assisted low anterior resection (lar) procedure, the jaw on the stapler 45 instrument would not unclamp, requiring the site to use the stapler release kit (srk). On 03/27/2017 intuitive surgical, inc. (isi) received additional information regarding the reported event from the site's robotics coordinator. According to the robotics coordinator, the surgeon was attempting to re-clamp the patient's sigmoid colon with the stapler 45 instrument and green reload installed, when an unspecified non-recoverable fault occurred. The robotics coordinator, stated that he attempted to use the srk in hole 1 of the stapler 45 instrument; however, the srk broke. The robotics coordinator indicated that the surgical staff shut the system down and all of the installed instruments were removed. The surgeon then created an abdominal incision, held the patient's colon and he was able to work the instrument's jaw off of the patient's tissue. According to the robotics coordinator the patient's pre-operative diagnosis was diverticulitis. The robotics coordinator indicated that as part of the planned surgical procedure, the surgeon was going to create the abdominal incision to perform extracorporeal techniques. However, due to the reported unclamp issue, the surgeon had to convert to open surgical techniques to continue with and complete the planned surgical procedure. The robotics coordinator indicated that there was no patient harm, adverse outcome or injury to the patient as a result of the reported issue. However, a larger abdominal incision was created because the surgeon had to complete the procedure using open surgical techniques. The patient was discharged from the hospital. According to the robotics coordinator, the stapler 45 instrument was inspected prior to use, and he did not observe any issues during his inspection of the instrument. There is no video recording of the planned surgical procedure and it is unknown what caused the reported unclamp issue.

• Brand Name: ENDOWRIST STAPLER 45
• Type of Device: ENDOSCOPIC INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL,INC.; sunnyvale CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC.; 950 kifer rd.; sunnyvale CA
• Manufacturer Contact: tabitha reed ; 950 kifer rd.; sunnyvale, CA ; 4085232420
• MDR Report Key: 6506322
• MDR Text Key: 73221225
• Report Number: 2955842-2017-00227
• 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: health professional

Reporter Occupation

• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 03/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 470298-11
• Device Lot Number: S10160923 0016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: ISIFA2017-02-C

Patient Treatment Data

Date Received: 04/19/2017 Patient Sequence Number: 1