MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LTD. EXCEL 23KHZ ANGLED HANDPIECE EACH1; ULTRASONIC SURGICAL PRODUCTS

Catalog Number C2601

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/15/2023

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

This is 2 of 2 reports linked to mfg report number 3006697299-2023-00131: a facility reported that after the 1st sterilization, a crack was observed on the cusa excel 23khz angled handpiece (c2601) at the time of 1st surgery.The patient was already under anesthesia when the dysfunction was observed, so a backup handpiece was used.There was no patient injury; however, there was increased surgery time of 1 hour.

Manufacturer Narrative

Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10 the cusa handpiece (c2601) was not returned for evaluation as per customer; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies during the manufacture or packaging that could be associated with the complaint incident was observed.Based on the reported failure of crack on the handpiece, the complaint may have been a result of cracked housing which is pending corrective action.However, without testing device it is not possible to verify.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

N/a.

• Brand Name: EXCEL 23KHZ ANGLED HANDPIECE EACH1
• Type of Device: ULTRASONIC SURGICAL PRODUCTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES (IRELAND) LTD.; sragh tullamore, co. offaly ; EI
• Manufacturer (Section G): INTEGRA LIFESCIENCES (IRELAND) LTD.; sragh tullamore, co. offaly ; EI
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 18427362
• MDR Text Key: 332502419
• Report Number: 3006697299-2023-00132
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10381780039426
• UDI-Public: 10381780039426
• Combination Product (y/n): N
• PMA/PMN Number: K141674
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/26/2024

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: C2601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 04/19/2024
• Supplement Dates FDA Received: 04/26/2024
• Date Device Manufactured: 08/25/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1