MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI X/XI; SMALL GRASPING RETRACTOR

Model Number 470318-10

Device Problem Break (1069)

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

Event Date 06/01/2021

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation confirmed the reported failure.Failure analysis found the grasping retractor had a broken pitch cable at the distal end.The broken cable segment that contains the crimp was still installed in the clevis.Root cause of this failure is attributed to a component failure.Additional findings not reported by the initial reporter: the instrument was found to have various scratch marks on the main tube that measured approximately 0.134 - 0.164" in length and were not aligned with the tube axis.The root cause of scratch marks/abrasions on the main tube is typically mishandling.A review of the instrument log for the product associated with this event shows that the small grasping retractor was last used on (b)(6) 2021 on system (b)(4).There is no indication that the instrument was used in subsequent procedures after the alleged event reported on this record.A review of the site's complaint history does not show any additional complaints related to this product.The alleged event occurred with 7 uses remaining on the instrument.No image or video clip for the reported event was submitted for review.This complaint is being reported due to the following conclusion: this instrument is designed with two pitch cables, each with a crimp at the distal end.If a pitch cable breaks at the distal end, a cable segment and/or the crimp could fall into the patient.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 sigmoid colectomy surgical procedure, the 8mm small grasping retractor wire snapped at the wrist.A backup of the same instrument was used to complete the procedure.There was no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the customer is unable to provide additional patient demographics and/or information.

• Brand Name: ENDOWRIST;DAVINCI X/XI
• Type of Device: SMALL GRASPING RETRACTOR
• 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: 12223601
• MDR Text Key: 263434585
• Report Number: 2955842-2021-10861
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112441
• UDI-Public: (01)00886874112441(11)210122(10)N10210125
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• 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: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470318-10
• Device Catalogue Number: 470318
• Device Lot Number: N10210125 0006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Date Manufacturer Received: 07/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2021
• 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
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 73 YR
• Patient Weight: 72