MAUDE Adverse Event Report: MAKO SURGICAL CORP. RIO® DRAPE KIT-ONE PIECE WITH POCKETS-; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 111320

Device Problems Material Split, Cut or Torn (4008); Non Reproducible Results (4029)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/03/2019

Event Type  malfunction  

Manufacturer Narrative

As part of the normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.

Event Description

(b)(4), mako product specialist reported the following event: " i would like to report the defects observed on 2 sheets for mako (113120 rio® drape kit, one piece with pockets) which were torn when they opened at the (b)(6) clinic in (b)(6).The first one during a surgery on (b)(6) 2019, and the second one on (b)(6).In both cases, the tear was in the same place, in the area where the end-effector was attached.I am attaching the photo of the label of one of the 2 damaged sheets, the other one could not be recovered from the operating room bin.This had no impact on the surgery, as an additional sheet was simply opened in each case." update: the patient was under anesthesia when the drape was opened, and the tear immediately discovered.The tear was not induced when opening the drape, it was already there.Note please reference (b)(4) for documentation on 1st complaint reported above.

Manufacturer Narrative

Reported event: it was reported that the drape was damaged during installation.Product evaluation and results: the product was not evaluated as the product was unavailable for inspection.Product history review: review of the product history records indicate (b)(4) were manufactured under lot no d182061 and accepted into final stock on 07/27/2018.No non-conformance were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 2053545, lot d182061 shows no additional complaints related to the failure in this investigation.Conclusions: the failure could not be determined as the product was not available for inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been no nc and capa associated with the product and failure mode reported in this event.H3 other text : product was not available for evaluation.

Event Description

Gauthier croizat mako product specialist reported the following event : " i would like to report the defects observed on 2 sheets for mako (113120 rio® drape kit, one piece with pockets) which were torn when they opened at the saint jean clinic in montpellier.The first one during a surgery on (b)(6) 2019, and the second one on april 3.In both cases, the tear was in the same place, in the area where the end-effector was attached.I am attaching the photo of the label of one of the 2 damaged sheets, the other one could not be recovered from the operating room bin.This had no impact on the surgery, as an additional sheet was simply opened in each case." update: the patient was under anesthesia when the drape was opened, and the tear immediately discovered.The tear was not induced when opening the drape, it was already there.Note: please reference (b)(4) for documentation on 1st complaint reported above.

• Brand Name: RIO® DRAPE KIT-ONE PIECE WITH POCKETS-
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8552141
• MDR Text Key: 145300918
• Report Number: 3005985723-2019-00319
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K050322
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 111320
• Device Lot Number: D182061
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization