MAUDE Adverse Event Report: ACCLARENT, INC. TRUDI NAV SUCTION, 70 - 1PK

Catalog Number TDNS070Z

Device Problem Calibration Problem (2890)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, weight, race, ethnicity, and medical history were not provided.The device does not have an expiration date as it is a non-sterile re-usable device.The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.A corrective and preventive action (capa) has been initiated to document investigation into the root cause and all corrective / preventative actions taken.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3005172759-2019-00117 and 3005172759-2019-00118.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Event Description

On (b)(6) 2019 acclarent identified 3 lots of trudi¿ nav suction instruments (0°, 70° & 90°) that were distributed to customers had a calibration issue in one of their components.This calibration issue caused an incorrect tip orientation display in the trudi¿ system that is used in conjunction with the device.The surgeon still has a functioning endoscopic view in addition to the location feature of the trudi¿ system.No adverse events have been reported for this incident.On (b)(6) 2019 acclarent initiated a removal of these lots in the field for the potential safety risk associated with the incorrect tip orientation display.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: on march 4, 2019 acclarent identified 3 lots of trudi¿ nav suction instruments (0°, 70° & 90°) that were distributed to customers had a calibration issue in one of their components.This calibration issue caused an incorrect tip orientation display in the trudi¿ system that is used in conjunction with the device.The surgeon still has a functioning endoscopic view in addition to the location feature of the trudi¿ system.No adverse events have been reported for this incident.On march 5, 2019 acclarent initiated a removal of these lots in the field for the potential safety risk associated with the incorrect tip orientation display.The product was received by the product analysis lab on 3/18/2019.The investigational finding is documented below.Investigation summary: the 70-degree trudi navigation suction device was received on march 18, 2019.Before decontamination, the returned device underwent visual inspection and was observed to have no obvious damage.The device underwent decontamination for two hours with a 10% bleach solution.The returned device underwent electrical testing using the lab multimeter (calibration date: 2/1/2019; due 2/29/2020.Below are the results of the electrical testing: knob position purpose pass criteria results sensor-sensor connectivity 200 o ±25 o (196.7o).2 connectivity of shield to device stainless steel body < 10 o (1.3 o).3 eeprom connectivity > 50 ko and < 10mo (656.0 o).4 isolation between sensor and shield > 1 mo (0l mo).5 isolation between sensor and eeprom io > 1 mo (0l mo).6 isolation between sensor and eeprom gnd > 1 mo (0l mo).7 isolation between shield and eeprom io > 1 mo (0l mo).8 isolation between shield and eeprom gnd > 1 mo (0l mo).The electrical test results underwent further review was performed on march 25, 2019.It was identified that it is possible to obtain a false failure reading on knob 3.As a result, the electrical testing was updated to add a note to allow for the testing to be repeated in opposite sequence in the event of having a value that does not meet the pass criteria for the eeprom connectivity test.This was to align with the test method currently implemented during manufacturing and at viant medical.Electrical testing was performed on the returned device again on march 27, 2019 using the lab multimeter (calibration date: 2/1/2019; due 2/29/2020.Below are the results of the electrical testing: knob position purpose pass criteria results sensor sensor connectivity 200 o ±25 o (196.7o) 2 connectivity of shield to device stainless steel body < 10 o (1.3 o).3 eeprom connectivity > 50 ko and < 10mo (448.5 ko).4 isolation between sensor and shield > 1 mo (0l mo).5 isolation between sensor and eeprom io > 1 mo (0l mo).6 isolation between sensor and eeprom gnd > 1 mo (0l mo).7 isolation between shield and eeprom io > 1 mo (0l mo).8 isolation between shield and eeprom gnd > 1 mo (0l mo).The returned complaint device was confirmed to meet testing specification / requirements.The returned complaint device was plugged into a trudi¿ unit (kt-2004-00f, sf version 1.3.0.21) and the following was observed: incorrect tip orientation display in the trudi¿ system.The issue calibration issue was confirmed / verified with the analysis testing performed on the returned complaint device.A corrective and preventive action (capa) has been initiated to document investigation into the root cause and all corrective / preventative actions taken.The lot history record (lhr) was reviewed for this lot (1901177).A non-conformance report (ncr) was initiated for the issue ¿bending die has damage which is causing a burr to form during the bending operation.¿ 39 of the 60 from the batch were implicated, but all 39 units implicated were rejected.The non-conformance report issue was unrelated to the complaint.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3005172759-2019-00117 and 3005172759-2019-00118.

Manufacturer Narrative

Manufacturer¿s ref.No (b)(4).The purpose of this mdr is to correct the manufacture information.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3005172759-2019-00117 and 3005172759-2019-00118.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product was received by acclarent product analysis lab on 3/18/2019.The return product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3005172759-2019-00117 and 3005172759-2019-00118.

• Brand Name: TRUDI NAV SUCTION, 70 - 1PK
• Type of Device: TRUDI NAV SUCTION, 70
• Manufacturer (Section D): ACCLARENT, INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 8429160
• MDR Text Key: 140147998
• Report Number: 3005172759-2019-00117
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 10705031245884
• UDI-Public: 10705031245884
• Combination Product (y/n): N
• PMA/PMN Number: K180948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TDNS070Z
• Device Lot Number: 1901177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Date Manufacturer Received: 04/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 03182019-001-R
• Patient Sequence Number: 1