MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; FENESTRATED BIPOLAR FORCEPS

Model Number	428093-16
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	09/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
61 - isi received the fenestrated bipolar forceps instrument associated with this complaint and completed its investigation.Failure analysis (fa) confirmed the customer reported issue - the twisted jaw and screw of a fenestrated bipolar forceps instrument broke off.The instrument was found to have broken grip tips.Both grips were no longer secured at the distal end.One grip was returned by the customer.The other grip, measuring approximately 0.96" x 0.20" was missing and not returned.The clevis was also found broken.Both clevis ears were no longer attached.One clevis ear was returned by the customer.The other clevis ear was not returned.Material, measuring approximately 0.33" x 0.20" was not returned with the clevis ear.The electrical spacer and electrical contact were also missing from the end.The spacer, measuring approximately 0.34" x 0.05" was not returned.The electrical contact, measuring approximately 0.10" x 0.05" was also not returned.The clevis pin holding the grip and clevis together was also missing.Material, measuring approximately 0.21" x 0.04" was not returned.The known common cause of these failures at the grip assembly is mishandling/misuse.Per the following excerpts from the instruments & accessories manual: unless it is stated, do not use single-site instruments on cartilage, bone or hard object.Doing so may damage the instrument and make it impossible to remove it from the cannula.Use instruments with care.Avoid contact between instruments intraoperatively and do not use one instrument to apply force to another instrument inside the patient.Do not use an instrument to clean debris from another instrument inside the patient.This may result in damage to the instruments or other unintended consequences, such as disconnection of the instrument tip.To clean an instrument intraoperatively, remove the instrument from the system and wipe the tips with sterile moistened gauze.Endoscopic instruments are designed and manufactured for a specific surgical function.Use of an instrument for a task other than that for which it is intended may result in a damaged or broken instrument.Based on the information provided at this time, this complaint is being reported due to the following conclusion: during a during a da vinci-assisted surgical procedure, fragments from a fenestrated bipolar forceps instrument allegedly broke off inside the patient and one fragment was not found or retrieved.However, there is no indication that a malfunction of the instrument occurred.The instrument damage found by fa can be attributed to mishandling/misuse.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 total benign hysterectomy surgical procedure, the fenestrated bipolar forceps installed on arm 1 was stuck.The intuitive surgical, inc.(isi) clinical sales representative (csr) called an isi technical support engineer (tse) to report that the instrument jaws were stuck open and could not be retracted through the trocar.The tse was unable to view the system logs.The tse had the surgical staff remove the instrument installed on arm 2 and partially retract its trocar for visualization.The surgical staff attempted to pull the instrument through the trocar but the instrument jaws would not close under pressure.The csr informed the tse that one of the jaw halves was twisted to the side.While attempting to remove the instrument, the twisted jaw and a screw reportedly fell inside the patient.The surgical staff was eventually able to remove the instrument from its trocar.The surgeon then elected to convert from a single-site to a multi-port da vinci-assisted surgical procedure.The surgical staff was able to retrieve one of the broken instrument pieces, the jaw portion.However, the surgical staff was unable to retrieve the other smaller piece, a screw, which fell inside the abdominal cavity.The procedure was completed robotically.On 09/11/2019, isi followed up with the initial reporter and obtained the following additional information: the procedure was completed by converting to a multi-port robotics surgery from a single-port surgical procedure.A piece of the insulation had fallen inside the abdominal cavity of the patient which had not been retrieved.

• Brand Name: ENDOWRIST
• Common Device Name: FENESTRATED BIPOLAR FORCEPS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 9164556
• Report Number: 2955842-2019-10776
• Device Sequence Number: 16649843
• Product Code: NAY
• UDI-Device Identifier: 00886874112106
• UDI-Public: (01)00886874112106(17)200731(10)M10180713
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K130726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/09/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: 428093-16
• Device Lot Number: M10180713 276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 10/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other