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

Catalog Number C2602

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A sales representative reported on behalf of the customer that the c2602 cusa excel 36khz straight handpiece failed during surgery on an unspecified date.The handpiece alarm was going off after pressing test.The sales representative disconnected the handpiece and put it all back together again to make sure the technician didn't make an error and got the same problem.They pulled another handpiece to check to see if that would work and it did with no alarms.There was no patient injury reported.Additional information has been requested.

Manufacturer Narrative

The product was returned for evaluation and the technician found that the handpiece amplitude dropped down to 10%.The device history record (dhr) review showed no abnormalities that could be associated with the complaint incident.The reported failure was confirmed.The cause of the complaint incident was due to a faulty transducer.Udi: (b)(4).

• Brand Name: CUSA EXCEL 36KHZ STRAIGHT HANDPIECE
• 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: 8775694
• MDR Text Key: 150603095
• Report Number: 3006697299-2019-00077
• Device Sequence Number: 1
• Product Code: LBK
• Combination Product (y/n): N
• PMA/PMN Number: K141674
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• 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: 06/27/2019
• Date Manufacturer Received: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1