MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; CURVED-TIP STAPLER 30

Model Number 470530-08

Device Problems Mechanical Problem (1384); Retraction Problem (1536)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/18/2021

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the curved-tip stapler 30 instrument involved with this complaint and completed the device evaluation.Failure analysis confirmed but did not replicate the reported complaint.The instrument was found to have a firing failure during in-house testing.The root cause was not determinable.The instrument was placed and driven on an in-house system.The instrument passed initialization and moved intuitively with full range of motion in all directions.The jaw opened and closed properly and the instrument clamped, fired and unclamped without any issues.An additional observation that was not reported by the site was identified during analysis of the instrument.Based on the log review, the instrument had a shifting failure and an engagement failure.These cause of these failures identified in the logs was not determinable.Isi also received two stapler 30 green reloads (part number 48630g-04 / lot number m90190719 0322 and part number 48630g-04 / lot number m90190719 0321) used during the reported event and performed evaluation.Analysis findings for both reloads were the same.Failure analysis replicated/confirmed the customer-reported complaint "stapler fired twice and stopped with blade out both times." the reloads were found to have the knife exposed within the knife track.The reloads were found to have a firing failure based on log review.The root cause of this failure is attributed to a component failure.Failure analysis also identified an additional observation not reported by the site for both reloads.The reloads were disassembled in-house for inspection and were found to have cartridge damage.No damage to the lead screw or the knife was observed.The root cause of this failure is attributed to mishandling/misuse.A review of the site's complaint history found no complaints for this instrument or reloads for any other event.No image or procedure video was provided for review.A review of the instrument log for the curved-tip stapler 30 instrument (part number: 470530-08, lot number: t10210204-0038) associated with this event has been performed.Per logs, the instrument was last used on (b)(6) 2021 on system (b)(4).The instrument was used for 15 minutes and it was used 3 times during the procedure.The instrument had 41 uses remaining out of 50 maximum uses.This complaint is reportable due to the following: it was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the curved-tip stapler 30 instrument had ¿exposed blade¿ error message after firing twice.No fragment fell into the patient.The procedure was completed with no injury to the patient.The instrument was returned and evaluated by the failure analysis team.Failure analysis confirmed a shifting failure occurred in a clamped state with no evidence of user mishandling/misuse.Medical intervention may be required in the event that the stapler fails to unclamp from tissue when commanded by the user or system.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 pulmonary lobectomy surgical procedure, the curved-tip stapler 30 instrument had ¿exposed blade¿ error message after firing twice.No fragment fell into the patient.The procedure was completed with no injury to the patient.Intuitive surgical (is) made multiple attempts to contact the reporter to obtain additional information about the complaint; however, attempts were not successful.

• Brand Name: ENDOWRIST
• Type of Device: CURVED-TIP STAPLER 30
• 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: david wang ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 12381316
• MDR Text Key: 268667238
• Report Number: 2955842-2021-11021
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112717
• UDI-Public: (01)00886874112717(10)T10210204
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/03/2021

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: 470530-08
• Device Catalogue Number: 470530
• Device Lot Number: T10210204 0038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2021
• Initial Date FDA Received: 08/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2021
• 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