MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) UNKNOWN CUSA EXCEL; ULTRASONIC SURGICAL PRODUCTS

Catalog Number XXX-CUSA

Device Problem Output Problem (3005)

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

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 1 of 3 reports linked to mfg report numbers 3006697299-2023-00090 and 3006697299-2023-00091: a facility reported that during use of the cusa excel handpiece (unknown catalog#), the cusaexcel9 console emitted a "cooling alarm." additional information was received as follows: when was the issue discovered (before, during, after surgery)? answer : during.Was the patient already under anesthesia? answer : yes.Was the patient injured? if yes, please describe injury and treatment.Answer : no.Did the event lead to increase surgery time? if yes, for how long? answer : maybe 30 minutes, they had to change the handpiece two times.The third and last handpiece gave no problems.How did the medical staff finish the procedure (using replacement unit)? answer : see above answer.

Manufacturer Narrative

The cusa device was returned for evaluation: device history record (dhr) - the dhr documentation was reviewed and no anomalies during the manufacture or packaging that could be associated with the incident was observed.Failure analysis - the investigation of the unit confirmed the complaint: during testing, a cooling alarm was detected caused by the crack in the housing.The transducer was found to be twisted in the handpiece housing due to user's mistake in not using the torque base or incorrectly using it.The soldered joints on the coil form have been resoldered, and the housing and all o-rings have been replaced.In addition, the handpiece has been recalibrated, tested and passed all the testing.Root cause - the root cause is confirmed as handpiece overtorquing and coilform.The overtorquing of the handpiece is 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.A corrective and preventative action (capa) has been raised to investigate the primary impact dissemination of information, for example, post operative intervention for purposes of removing the tip and cleaning.

• Brand Name: UNKNOWN CUSA EXCEL
• 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
• Manufacturer (Section G): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17624214
• MDR Text Key: 322615377
• Report Number: 3006697299-2023-00089
• 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: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: XXX-CUSA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2011
• 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