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

Model Number 471205-17

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 10/21/2021

Event Type  malfunction  

Event Description

It was reported that during central processing, a fenestrated bipolar forceps instrument had melted plastic at the distal end.No patient was involved with this event.Intuitive surgical inc.(isi) contacted the original reporter and obtained the following information on 4-nov-2021.The instrument arrived already damaged before it was provided to central processing.Patient information from the last procedural use of the instrument was requested, but was not available.No further details were provided.

Manufacturer Narrative

Intuitive surgical, inc.(isi) has not yet received the fenestrated bipolar forceps for evaluation.Therefore, the root cause of the customer reported failure mode could not be determined.A follow-up mdr will be submitted if the instrument is returned (post failure analysis evaluation) or if additional information is received.A review of the site's complaint history does show any complaints for other issues related to this product.No image or video clip for the reported event was submitted for review.A review of the instrument log of the fenestrated bipolar forceps (part # 471205-17 / lot # n11210726-0296) associated with this event has been performed.Per the logs, the instrument was last used on (b)(6) 2021 on system sk0955.The alleged event occurred on the 8th use of the instrument.Based on the information provided, this complaint is considered a reportable malfunction due to the following conclusion: it was alleged that a fenestrated bipolar forceps instrument had melted plastic at the distal end.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

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

D11 - intuitive surgical, inc.(isi) received the fenestrated bipolar forceps instrument involved with this complaint and completed the device evaluation.Fa was able to confirm/reproduce the reported complaint.The instrument was found to have charring and localized melting at the grip base between the grips.The instrument passed the electrical continuity test.No damage was found to the insulation of the conductor wire or to the conductor wire.Root cause of this failure is attributed to mishandling/misuse and most commonly caused by insulation degradation and carbonized tissue creating a conductive path.Based on the failure analysis results, the damage to the instrument was found to be due to mishandling/misuse and not due to a malfunction of the instrument.

• Brand Name: ENDOWRIST
• Type of Device: FENESTRATED BIPOLAR FORCEPS
• 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: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 12818208
• MDR Text Key: 280801842
• Report Number: 2955842-2021-11515
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119808
• UDI-Public: (01)00886874119808(10)N11210726
• 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,Followup
• Report Date: 10/21/2021

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: 471205-17
• Device Catalogue Number: 471205
• Device Lot Number: N11210726 0296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Initial Date Manufacturer Received: 10/21/2021
• Initial Date FDA Received: 11/16/2021
• Supplement Dates Manufacturer Received: 11/17/2021
• Supplement Dates FDA Received: 12/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2021
• 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