MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; INSTRUMENT SHEATH

Model Number 430012-14

Device Problem Material Separation (1562)

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

Event Date 02/26/2024

Event Type  malfunction  

Event Description

It was reported that prior to the start of a da vinci-assisted radical hysterectomy surgical procedure and prior to ports placement, a single-port (sp) instrument sheath was torn apart.The detached piece was attached to the instrument shaft.The customer used mosquito forceps to remove the sheath piece from the instrument.The customer stated that the issue happened because the sheath was not attached properly due to slight overloading during installation.There was no damage to the sp instrument.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: it was confirmed that the sp sheath was discarded and will not be returned.

Manufacturer Narrative

Intuitive surgical, inc.(isi) did not receive the da vinci product with an alleged issue to perform failure analysis.The return authorization was not issued for return as the customer reported that the single-port sheath was discarded.Although the complaint was not confirmed by failure analysis since the product was not returned, the information gathered indicates that the device may have contributed to the customer reported issue.

• Brand Name: NONE
• Type of Device: INSTRUMENT SHEATH
• 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: 18918873
• MDR Text Key: 337850533
• Report Number: 2955842-2024-12514
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 30886874114347
• UDI-Public: (01)30886874114347(17)250831(10)K10230817
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K182371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 430012-14
• Device Catalogue Number: 430012
• Device Lot Number: K10230817
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2023
• 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
• Patient Sex: Female