MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; ENDOSCOPE PLUS

Model Number 470057-05

Device Problems Image Orientation Incorrect (1305); Material Integrity Problem (2978)

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

Event Date 02/08/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted robotic prostatectomy - radical extraperitoneal w/ lymphadenectomy surgical procedure, the endoscope plus has up and down that are backwards.The procedure was completed with no reported injury.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the endoscope involved with this complaint and completed the device evaluation.Failure analysis investigations confirmed and replicated the customer reported complaint.Analysis summary shows the reported issue is due to scope bearing friction issue.The endoscope was received with cable integrity visual damage in zone b.The endoscope was received with aea damaged or friction issue.Additional findings include the endoscope was received with distal tip straightness.Also, failure analysis investigations confirmed the endoscope was received with cable failed mipi signal transmission.The endoscope was received with hirose light level on.The payload test passed.Blank mdr fields: the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Information for the blank fields in section e1 is not available.Field e4 is blank because it is unknown if the initial reporter submitted a report to the fda.Fields g5 and g7 are not applicable.

• Brand Name: NONE
• Type of Device: ENDOSCOPE PLUS
• 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: 17039729
• MDR Text Key: 317209842
• Report Number: 2955842-2023-15428
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00886874116555
• UDI-Public: (01)00886874116555
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191736
• 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
• Report Date: 03/01/2022

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: 470057-05
• Device Catalogue Number: 470057
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2022
• Initial Date Manufacturer Received: 03/01/2022
• Initial Date FDA Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Sex: Male