MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA EXCEL 23KHZ STRAIGHT HANDPIECE; ULTRASONIC SURGICAL PRODUCTS

Catalog Number	C2600
Medical Device Problem Code	Misassembled During Installation (4049)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
This is 2 of 2 reports for the 2nd handpiece, and linked to mfg report number 3006697299-2024-00121: a facility reported that the first cusa excel 23khz straight handpiece (c2600) did not work so they wanted to use the second cusa handpiece which did not work also as it was misaligned.They managed to realign it and use it for the surgery.The issue was detected before surgery; however, there was no injury.Additional information was received as follows: did the problem appear before an operation (patient prepared/under anesthesia)? yes.Did the problem lead to an increase in the duration of the procedure (= or > 30 minutes)? 30 minutes.Did this incident have any consequences for the patient? no.The second hp work.They detected the discrepancy between irrigation tube and the part that permit insertion of the tube.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The cusa excel 23khz straight handpiece (c2600) was returned for evaluation: device history record (dhr) ¿ the dhr was reviewed and no anomalies that could be associated with the complaint incident was observed.Failure analysis - the investigation of the unit confirmed the complaint: the device is overtorqued.To resolve the issues, the housing and all o-rings have been replaced and a full function test including calibration and safety test according to manufacturer's specification have been performed.Root cause - the root cause is confirmed as overtorquing due to incorrect assembly and disassembly of the handpiece by the customer using the torque wrench.This resulted in the torque wrench misaligning the dot on the handpiece and the handpiece connector.In relation to the handpiece overtorquing, corrective action has been raised to investigate this issue and is pending corrective action.This will be monitored and trended going forward.At present, we consider this complaint to be closed.

• Brand Name: CUSA EXCEL 23KHZ STRAIGHT HANDPIECE
• Common Device Name: ULTRASONIC SURGICAL PRODUCTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer (Section G): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 20012756
• Report Number: 3006697299-2024-00122
• Device Sequence Number: 4431640
• Product Code: LFL
• UDI-Device Identifier: 10381780039419
• UDI-Public: 10381780039419
• Combination Product (Y/N): N
• PMA/510(K) Number: K141674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: C2600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3006697299-05/29/2024-00
• Patient Sequence Number: 1
• Patient Sex: Unknown