MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; PERMANENT CAUTERY HOOK

Model Number 470183-14

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 09/15/2021

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received permanent cautery hook instrument involved with this complaint and completed the device evaluation.During failure analysis, the customer reported issue was confirmed.The instrument was found to have a broken pitch cable at the distal end.The broken cable segment that contains the crimp was still installed in the clevis.No thermal damage was found.Pitch cable breakage occurs when tensile load exceeds the ultimate strength of the material.The pitch cable construction is designed to optimize load and fatigue (cycling) characteristics.Variation in customer use conditions, procedure type, patient anatomy, product handling, instrument tip lengths, grip torque, and manufacturing tolerances are a few variables which can influence pitch cable failure.Pitch cable damage is indicative of a component failure and related to device design.As part of investigation, instrument was further evaluated and unrelated observations were identified.First was a dislodged ceramic sleeve.No missing material was confirmed on the area of dislodgement.This failure is manufacturing related.Second, identified various scratch marks measuring approximately 0.044¿ to 0.168" with light material removed on the main tube.The scratch marks were not aligned with the tube axis.Third, found a dislodged flush tube guide.Last was a dislodged idler pulley shaft.The scratches on the main tube and dislodged flush tube guide and idler pulley shaft are known to be caused by mishandling and misuse.Aa review of the site's complaint history does not show any additional complaints related to this product and/or this event.A review of the instrument log for the permanent cautery hook instrument lot# n10190106 / sequence 0003 associated with this event has been performed.Per logs, the instrument was last used on the reported event date on (b)(6) 2021 on system sk2102.The alleged event occurred on the 8th use of the instrument.The instrument has 2 remaining usable lives with no subsequent use recorded.No procedure video or image was submitted to isi for review.This complaint is considered a reportable malfunction due to the following conclusion: this instrument is designed with two pitch cables, each with a crimp at the distal end.If a pitch cable breaks at the distal end, a cable segment and/or the crimp could fall into the patient.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.Blank mdr fields: follow-up was attempted, but the patient information in sections was either unknown, unavailable, not provided, or not applicable.Device expiration date for section was left blank as this instrument has 10 usages allotted to it, which are tracked by the da vinci surgical system.The instrument has 2 remaining usable lives, therefore, had not expired.Field is blank because the product is not implantable.Information for the blank fields in section is not available.Fields are not applicable.

Event Description

It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the wire of the permanent cautery hook instrument broke.A backup instrument of same kind was used to complete the procedure.No fragment fell into the patient.The procedure was completed with no reported injury.

Event Description

It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the wire of the permanent cautery hook instrument broke.A backup instrument of same kind was used to complete the procedure.No fragment fell into the patient.The procedure was completed with no reported injury.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received permanent cautery hook instrument involved with this complaint and completed the device evaluation.During failure analysis, the customer reported issue was confirmed.The instrument was found to have a broken pitch cable at the distal end.The broken cable segment that contains the crimp was still installed in the clevis.No thermal damage was found.Pitch cable breakage occurs when tensile load exceeds the ultimate strength of the material.The pitch cable construction is designed to optimize load and fatigue (cycling) characteristics.Variation in customer use conditions, procedure type, patient anatomy, product handling, instrument tip lengths, grip torque, and manufacturing tolerances are a few variables which can influence pitch cable failure.Pitch cable damage is indicative of a component failure and related to device design.As part of investigation, instrument was further evaluated and unrelated observations were identified.First was a dislodged ceramic sleeve.No missing material was confirmed on the area of dislodgement.This failure is manufacturing related.Second, identified various scratch marks measuring approximately 0.044¿ to 0.168" with light material removed on the main tube.The scratch marks were not aligned with the tube axis.Third, found a dislodged flush tube guide.Last was a dislodged idler pulley shaft.The scratches on the main tube and dislodged flush tube guide and idler pulley shaft are known to be caused by mishandling and misuse.Aa review of the site's complaint history does not show any additional complaints related to this product and/or this event.A review of the instrument log for the permanent cautery hook instrument lot# n10190106 / sequence 0003 associated with this event has been performed.Per logs, the instrument was last used on the reported event date on (b)(6) 2021 on system sk2102.The alleged event occurred on the 8th use of the instrument.The instrument has 2 remaining usable lives with no subsequent use recorded.No procedure video or image was submitted to isi for review.This complaint is considered a reportable malfunction due to the following conclusion: this instrument is designed with two pitch cables, each with a crimp at the distal end.If a pitch cable breaks at the distal end, a cable segment and/or the crimp could fall into the patient.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.Blank mdr fields: follow-up was attempted, but the patient information in sections was either unknown, unavailable, not provided, or not applicable.Device expiration date for section was left blank as this instrument has 10 usages allotted to it, which are tracked by the da vinci surgical system.The instrument has 2 remaining usable lives, therefore, had not expired.Field is blank because the product is not implantable.Information for the blank fields in section is not available.Fields are not applicable.

• Brand Name: ENDOWRIST
• Type of Device: PERMANENT CAUTERY HOOK
• 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: 13007730
• MDR Text Key: 285755230
• Report Number: 2955842-2021-11747
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112311
• UDI-Public: (01)00886874112311(10)N10190106
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470183-14
• Device Catalogue Number: 470183
• Device Lot Number: N10190106 0003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Date Manufacturer Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2019
• 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 Age: 81 YR
• Patient Sex: Male