MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; FORCE BIPOLAR

Model Number 470405-06

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/08/2020

Event Type  Injury  

Manufacturer Narrative

The force bipolar instrument has not been returned to intuitive surgical inc.(isi) for failure analysis evaluation; therefore, the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if the accessory is returned (post engineering evaluation) or if additional information is received.Verification of the event details could not be performed because system logs from the site were not available.No image or video was provided.This complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, the force bipolar instrument broke and two pieces fell inside of the patient.The broken pieces were retrieved during the same procedure.Although, no patient harm, adverse outcome or injury was reported, it is unknown what caused the force bipolar instrument to break.Additionally, if the failure were to recur, it could cause or contribute to an adverse event.Follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.Implant date is blank because the product is not implantable.Initial reporter is blank because it is unknown if the initial reporter submitted a report to the fda.Recall is not applicable.

Event Description

It was reported that during a da vinci-assisted prostatectomy surgical procedure, while dissecting, the force bipolar instrument broke into two pieces and fell inside a patient.The fragments were retrieved during the same procedure.There was no collision noted.The instrument wrist was straightened upon instrument removal.The procedure was completed with no reported injury.Intuitive surgical inc.(isi) made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.

Event Description

Refer to h10/h11 for follow-up information.

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.Corrected information can be found the following field: b1, b2, and h1 b1 updated from "product problem" to "adverse event and product problem" b2 updated to "required intervention".H1 updated from "malfunction" to "serious injury".

• Brand Name: ENDOWRIST
• Type of Device: FORCE BIPOLAR
• 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: 11099550
• MDR Text Key: 224532894
• Report Number: 2955842-2020-11428
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874115930
• UDI-Public: (01)00886874115930(10)N10201006
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180351
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470405-06
• Device Catalogue Number: 470405
• Device Lot Number: N10201006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.; DA VINCI INSTRUMENTS AND ACCESSORIES.
• Patient Age: 62 YR
• Patient Sex: Male