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

Model Number 470298-14

Device Problems Difficult to Open or Close (2921); Mechanical Jam (2983)

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

Event Date 07/16/2020

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the stapler 45 instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation replicated/confirmed the customer reported complaint.The stapler 45 instrument was found to have an unclamp failure based on a log review.The stapler 45 instrument was found to have the grip cables broken in the proximal end.The stapler 45 instrument was also found to have the idler pulley cover missing.A review of the site's complaint history revealed that the stapler 45 white reload and the stapler sheath used during this procedure were also returned for fa.The stapler 45 white reload was found to have no issues.Upon visual inspection, the stapler 45 white reload appeared to be used and completely fired without any issues.A review of the remotefe logs found no firing failures.The stapler 45 white reload was disassembled in-house for inspection and found no damages.The stapler sheath was found to have a tear.A missing piece from the stapler sheath was not returned.The tear was approximately 0.035" x 0.063".This failure is most commonly caused by mishandling/misuse.A review of the instrument log showed the stapler 45 instrument (part #470298-14 / lot #t11200508 0028) was last used on (b)(6) 2020 during this procedure with system (b)(4).The stapler 45 instrument has 50 allotted uses.The stapler 45 instrument has 43 lives left.The stapler 45 instrument has not been used in subsequent procedures after the alleged event reported on this record.No image or video clip for the reported event was submitted for review.Based on the information provided at this time, this complaint is being reported due to the following conclusion: the stapler 45 instrument was unable to unclamp or incurred a failure mode that is known to prevent unclamping of the instrument jaws.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the stapler 45 instrument misfired over a vessel, and it would not open.The customer had to use a stapler release kit (srk) to unclamp and remove the stapler 45 instrument.The customer continued the procedure with a backup stapler 45 instrument.The procedure was completed with no report of patient harm, injury or adverse outcome.Intuitive surgical, inc.(isi) obtained the following additional information regarding the reported event: the site was performing a da vinci assisted laparoscopic sigmoid colectomy surgical procedure.The stapler 45 instrument and stapler 45 white reload were inspected prior to use and no issues were noted.The surgeon was stapling an arterial vessel that supplies blood to the sigmoid portion of the colon at the time of the event.The stapler 45 instrument clamped down on a vessel and fired successfully, but the jaws would not open.There was a message stating ¿robot was not able to open stapler.¿ the surgeon chose the stapler 45 white reload because the vessel fits the parameters of this stapler 45 white reload.The stapler 45 instrument performed as intended up until the reported event.The stapler 45 instrument had 45 of 50 staple fires left to use.The reported event involved the first fire for the case.There were no messages prior to or during the stapling process.There were no obstructions between the jaws of the stapler 45 instrument.There were no clamping issues prior to firing the stapler 45 white reload.The target tissue was not calcified, nor exposed to radiation or chemotherapy.There was no tissue tension/bunching.The site had to use an srk to manually release the stapler 45 instrument.There was no adverse effect to the grasped tissue and no unexpected tissue removal.There was no unexpected bleeding.The nurse confirmed there was no harm to the patient.There are no photographic images or a video recording of the procedure.The customer was not able to provide information about the patient's medical history/tests nor the patient demographic information.

• Brand Name: ENDOWRIST
• Type of Device: STAPLER 45
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 10452387
• MDR Text Key: 212578491
• Report Number: 2955842-2020-10791
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112427
• UDI-Public: (01)00886874112427(10)T11200508
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470298-14
• Device Catalogue Number: 470298
• Device Lot Number: T11200508 0028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• Initial Date Manufacturer Received: 07/29/2020
• Initial Date FDA Received: 08/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2020
• 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