MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; SEAL

Model Number 470500-13

Device Problem Material Integrity Problem (2978)

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

Event Date 06/26/2023

Event Type  Injury  

Event Description

It was reported that during a da vinci-assisted inguinal hernia surgical procedure, a piece of the rubber from the universal seal fell into the patient's abdomen when the first assist inserted a blunt lap atraumatic prestige grasper.The console surgeon was able to get all the pieces out of the patient as it was confirmed by x-ray.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter on and obtained the following additional information: there was no injury to the patient.The patient has not returned to the hospital due to experiencing any post-surgical complications related to retaining a foreign object.

Manufacturer Narrative

Based on the claim against the product by the customer noting, a piece of the rubber universal seal fell into the patient's abdomen, an investigation is pending to determine the cause of this reported event.Intuitive surgical, inc.(isi) requested the return of the device for further evaluation.Additional information is being gathered to determine the contribution of the device to the customer reported issue.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Based on the claim against the product by the customer noting a piece of the rubber fell into the patient, an investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The universal seal accessory was analyzed and found to have a tear in the seal.The tear was located at the duckbill of the seal.However, the torn piece was not returned with the received seal.The missing piece was approximately 0.116" x 0.189" in size.The complaint was confirmed based on failure analysis, which indicates that the device did contribute to the customer-reported issue.

• Brand Name: NONE
• Type of Device: SEAL
• 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: 17511689
• MDR Text Key: 320900288
• Report Number: 2955842-2023-17659
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10886874116408
• UDI-Public: (01)10886874116408(11)230201(17)250131(10)K12230201
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181395
• 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: 07/18/2023

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
• Device Operator: Health Professional
• Device Model Number: 470500-13
• Device Catalogue Number: 470500
• Device Lot Number: K12230201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 07/18/2023
• Initial Date FDA Received: 08/11/2023
• Supplement Dates Manufacturer Received: 08/16/2023
• Supplement Dates FDA Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.