MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SINGLE-SITE; CADIERE FORCEPS

Model Number	478055-02
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did not receive the da vinci product with an alleged issue to perform failure analysis.Although the complaint regarding instrument breakage was not confirmed by failure analysis since the instrument was not returned, the information gathered indicates that the device did contribute to the customer-reported issue.The product has not been returned for evaluation.Therefore, the root cause of the customer-reported failure mode could not be determined.A follow-up mdr will be submitted if additional information becomes available.This is considered a reportable event due to the following conclusion: it was alleged that the instrument broke and a fragment fell inside the patient during a da vinci-assisted procedure.The fragment was retrieved during the same procedure.At this time, it is unknown what caused the breakage to occur.
Event or Problem Description
It was reported that after a da vinci-assisted benign hysterectomy surgical procedure, a single-site cadiere forceps instrument broke inside a patient.An intuitive surgical, inc.(isi) clinical sales representative (csr) informed the isi technical support engineer (tse) that an ¿adverse event" had occurred and indicated that an instrument had broken while in use inside a patient.The isi csr stated that all pieces were retrieved, and no other injury was reported.The isi tse recommended that the isi csr request for the customer to return the failed/damaged instrument for failure analysis.The procedure was completed.Isi made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.

• Brand Name: SINGLE-SITE
• Common Device Name: CADIERE 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: 16676082
• Report Number: 2955842-2023-11742
• Device Sequence Number: 5434880
• Product Code: NAY
• UDI-Device Identifier: 00886874113608
• UDI-Public: (01)00886874113608(10)S10160927
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K152448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/13/2023

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
• Operator of Device: Health Professional
• Device Model Number: 478055-02
• Device Catalogue Number: 478055
• Device Lot Number: S10160927 0015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2016
• 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: Female