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

Catalog Number C3600

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2020

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

A facility reported that prior to a liver surgery, the cusa excel 23khz tubing set was leaking and broken.There was no delay in surgery and patient was in good condition post procedure.

Manufacturer Narrative

Udi: (b)(4).The reported lot number documentation was reviewed and no anomaly was reported during its manufacturing, packaging, and inspection processes that could be related to a condition as the one reported.The reported condition of ¿broken and leakage¿ was confirmed during the evaluation of the returned c3600 cusa 23khz tubing set.The evaluation identified that the irrigation tube (with blue strip) was damaged and cracked.The damage observed in this section of the irrigation tube is consistent with the defect caused when the tube is incorrectly assembled into the pump latch and it is pinched under compression.The cusa excel user¿s guide provides the proper instructions for the tubing assembly into the console machine and also indicates a caution statement to avoid damages to the tube: ¿make sure that the irrigation tubing centers between the v-shaped tubing retainers before you close the pump latch.Otherwise, the pump latch will pinch the tubing, preventing the flow of irrigation fluid.¿ based on the unit evaluation, the possible root cause of the reported condition is related to an improper assembly of the tube into the console machine.

Event Description

N/a.

• Brand Name: CUSA EXCEL 23KHZ TUBING SET
• 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: 11102126
• MDR Text Key: 249690229
• Report Number: 3006697299-2020-00129
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• PMA/PMN Number: K141668
• 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: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: C3600
• Device Lot Number: 4275695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Date Manufacturer Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1