MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SINGLE-SITE; CROCKODILE GRASPER

Model Number	478059-03
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An intuitive surgical, inc.(isi) field service engineer (fse) followed up with clinical sales representative (csr).Csr confirmed that the surgeon was able to retrieve all broken pieces and verified via x-ray.The procedure was completed successfully.No site visit was conducted as the system was working properly and no additional action was required.The crocodile grasper instrument has not been returned for evaluation.Therefore, failure analysis of the product related to the complaint cannot be performed.A follow-up mdr will be submitted if additional information is received.A review of the site's complaint history does not reveal any additional complaints involving this product and/or this event.No image or procedure video was provided for review.A review of the instrument log for the crocodile grasper instrument (part number: 478057-03, lot number: s10170623-0003) associated with this event has been performed.Per logs, the instrument was last used on (b)(6) 2022 on system (b)(4).The instrument was used for 53 minutes.The instrument had 8 uses remaining out of 10 maximum uses.This complaint is considered a reportable malfunction due to the following conclusion: it was alleged that the instrument broke and fragments fell inside the patient during a da vinci assisted procedure.All fragments were successfully 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 during a da vinci-assisted cholecystectomy surgical procedure, an unknown instrument broke and fragments fell inside the patient.The customer performed an x-ray to confirm all fragments were retrieved.The procedure was completed as planned with no reported patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter (clinical sales representative) and obtained additional information: the affected instrument was a crocodile grasper (part number: 478059, lot number: s10170623 0003).The instrument was inspected prior to use and no damage was noted.The instrument was used for approximately two hours prior to the reported issue.The surgeon was lifting the liver to retract the gallbladder when the instrument broke and fragments fell inside the patient.Broken pieces were retrieved using a laparoscopic grasper instrument.All fragments were retrieved, and this was confirmed via vision side cart (vsc) and x-ray imaging.The surgeon did not notice any issues with the functionality of the instrument during the surgical procedure.The instrument did not collide with any other instruments or other hard material during the surgical procedure.

• Brand Name: SINGLE-SITE
• Common Device Name: CROCKODILE GRASPER
• 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: 13692649
• Report Number: 2955842-2022-10524
• Device Sequence Number: 1943705
• Product Code: NAY
• UDI-Device Identifier: 00886874113639
• UDI-Public: (01)00886874113639(10)S10170623
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/09/2022

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: 478059-03
• Device Catalogue Number: 478059
• Device Lot Number: S10170623 0003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2017
• 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: Unknown