MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) EXCEL 36KHZ STRAIGHT HANDPIECE EACH1; ULTRASONIC SURGICAL PRODUCTS

Catalog Number C2602

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/16/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not yet received by the manufacturer for evaluation.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A customer reported that no vibration was detected on the c2602 excel 36khz straight handpiece and alarms were triggered.This was noted during a test on (b)(6) 2020 before a procedure.There was no patient injury and no known surgery delay.

Manufacturer Narrative

Unique device identifier (udi): (b)(4).The device was returned for evaluation.Device history record (dhr) - the dhr documentation was reviewed and no anomalies that could be associated with the complaint incident was observed.The reported complaint was confirmed via evaluation of the unit.Date of manufacture 2019.Confirmed vibration test failure.Confirmed low amplitude.Confirmed defective transducer.This complaint is consistent with known issue transducer delamination.Root cause: transducer defect ( consistent with transducer delamination).Reported failure: does not comply with the vibration test ( confirmed).

Event Description

N/a.

• Brand Name: EXCEL 36KHZ STRAIGHT HANDPIECE EACH1
• Type of Device: ULTRASONIC SURGICAL PRODUCTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; ida business&technology park; sragh, tullamore, co.offaly ; EI
• MDR Report Key: 10389081
• MDR Text Key: 205331334
• Report Number: 3006697299-2020-00091
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• PMA/PMN Number: K141668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C2602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Date Manufacturer Received: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1