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

Catalog Number C2602

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

This is 3 of 3 reports linked to mfg report numbers: 3006697299-2021-00004, 3006697299-2021-00005.A facility reported that the cusa excel 36khz straight handpiece (c2602) failed during an unspecified surgery.There was no delay in surgery nor patient injury reported.Additional information has been requested.

Event Description

N/a.

Manufacturer Narrative

The cusa excel 36khz straight handpiece (c2602) was returned for evaluation: device history record (dhr): the dhr shows no abnormalities related to the reported failure.Failure analysis - the reported complaint was confirmed.Amplitude is 10%, squeal from handpiece.Root cause - a corrective action investigation has been initiated and is currently being implemented for transducer delamination.Recommend replacing the transducer, housing and o- rings before calibrating to manufacturer¿s specifications.

• 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: 11348316
• MDR Text Key: 232542618
• Report Number: 3006697299-2021-00006
• Device Sequence Number: 1
• Product Code: LFL
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 05/12/2021
• Initial Date Manufacturer Received: 01/21/2021
• Initial Date FDA Received: 02/19/2021
• Supplement Dates Manufacturer Received: 05/18/2021
• Supplement Dates FDA Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1