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

Model Number	370891-04
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The reported complaint was confirmed based on the field evaluation.The fse inspected the endoscope and confirmed one of the lens was dented.The left and right side of lens at the tip seems to be different.The fse advised the customer to replace the endoscope.The system was tested and verified as ready for use.The 30 degrees endoscope has not been returned for evaluation; therefore, the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if the instrument is returned (post engineering evaluation) or if additional information is received.A review of the provided image by rpms is consistent with the reported failure of a dented endoscope lens.The root cause of the failure mode cannot be confirmed without the returned device.No further escalations were required for the image review.The lot # was not provided.Therefore, an instrument log review of the product related to the complaint cannot be performed at this time.This complaint is being reported based on the following conclusion: the complaint alleged a fragment was missing from a portion of the device that enters the patient (distal end).Based on the information provided, there was no report from the customer that a fragment from the instrument fell into the patient during the procedure.While there was no report of 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 or Problem Description
It was reported that prior to the start of a da vinci-assisted simple prostatectomy surgical procedure, the 30 degrees endoscope had a missing lens at the tip.One of the lenses was dented.The procedure was continuing as planned with no reported injury.Intuitive surgical, inc.(isi) followed up with the medical engineer and obtained the following additional information: the reporter did not obtain information to deny fallen fragment into the patient's body.The nurse found the lens damage just before inserting the endoscope into the patient.The patient has not returned to the hospital due to experiencing any post-surgical complications related to retaining a foreign object.The customer will be returning the damaged endoscope.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the endoscope involved with this complaint and completed the device evaluation.Failure analysis confirmed the customer reported complaint.The endoscope was received with mechanical damage to the distal window assembly hermetic seal resulting in fluid invasion and fragments of the epoxy were possibly missing.Mechanical damage to the distal illumination fiber was also found and fragments of the fiber optic were missing.

• Brand Name: NONE
• Common Device Name: ENDOSCOPE
• 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: 14556406
• Report Number: 2955842-2022-11947
• Device Sequence Number: 12283204
• Product Code: NAY
• UDI-Device Identifier: 00886874110195
• UDI-Public: (01)00886874110195
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K081137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2022

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
• Operator of Device: Health Professional
• Device Model Number: 370891-04
• Device Catalogue Number: 370891
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/02/2022
• Supplement Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 08/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Male