MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; SMALL GRASPING RETRACTOR

Model Number	420318-05
Medical Device Problem Codes	Material Fragmentation (1261); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Isi has not received the small grasping retractor instrument for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if additional information is obtained.A review of the instrument log was performed.Per the review, the device was used on the reported event date of (b)(6) 2021 on system sh1080.The small grasping retractor had 5 use remaining after the last use.A review of the site's complaint history identified no other complaints related to the instrument and/or this event.No image or procedure video was provided for review.Based on the information available at this time, this complaint is being classified as a reportable event due to the following conclusion: during a surgical procedure, a fragment from the small grasping retractor instrument reportedly fell inside the patient.All fragments were retrieved during the same procedure and no additional surgical intervention was required.However, unintended fragment(s) falling into the patient may require surgical intervention.At this time, it is unknown what caused the breakage to occur.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the small grasping retractor instrument wire was broken and a fragment fell into the patient.The fragment was retrieved with a laparoscopic instrument during the same procedure.The procedure was completed with no reported injury.Intuitive surgical, ind.(isi) followed up with the customer and obtained additional information on 27-july-2021.The instrument was reportedly inspected prior to use and no issues were identified.The instrument was in use for an unknown amount of time, and no issues with the functionality were noted.There were no known collisions during the procedure.It was confirmed that the instrument fragment was retrieved successfully during the same procedure, there were no post-operative tests to look for additional fragments, and the patient has not returned to the hospital due to any post-surgical complications related to retaining a foreign object.
Additional Manufacturer Narrative
Additional information and updated information can be found in the following fields: d9, h3, h6, and h10.D02 - intuitive surgical, inc.(isi) received the small grasping retractor instrument involved with this complaint and completed the device evaluation.Failure analysis investigation revealed that the instrument was found to have a broken pitch cable at the distal clevis hub.The broken cable segment that contains the crimp was missing in the clevis.Missing crimp was approximately 0.046¿ x 0.032 and not returned with the instrument.Failure analysis found the primary failure of a broken pitch cable at the distal end of the instrument to be related to the customer reported complaint.Root cause of a broken pitch cable was a component failure and related to device design.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Based on a re-evaluation of the complaint information, this complaint has been reclassified as an adverse event and product problem rather than just a product problem, as previously reported.B1 updated from "product problem" to "adverse event and product problem".B2 updated to "required intervention".H1 updated from "malfunction" to "serious injury".
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: 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: 12363979
• Report Number: 2955842-2021-10987
• Device Sequence Number: 3901837
• Product Code: NAY
• UDI-Device Identifier: 00886874111802
• UDI-Public: (01)00886874111802(10)N10190227
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other,Inspection
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/26/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 420318-05
• Device Catalogue Number: 420318
• Device Lot Number: N10190227-474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/26/2021
• Supplement Date Received by Manufacturer: 08/26/2021; 07/26/2021
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 09/21/2021; 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES; DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American