MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) EXCEL 23KHZ TUBING SET BOX6; ULTRASONIC SURGICAL PRODUCTS

Catalog Number C3600

Device Problems Leak/Splash (1354); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/18/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not yet received by the manufacturer for evaluation.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

It was reported that a (b)(6) year old male patient undergone a right extended hepatectomy procedure on (b)(6) 2020.During the procedure, the c3600 excel 23khz tubing set began to leak through the cusa excel machine.The tubing was swapped out and the irrigation tubing had been damaged.There was no patient injury or death.There was a delay for five (5) to ten minutes when the tubing was swapped out.

Manufacturer Narrative

Additional information: d10, g4, g7, h2, h3, h4, h6, h10.Udi #: (b)(4).The device was not returned for evaluation therefore the failure analysis to identify root cause to the end user's experience could not be determined.The device history record was reviewed and showed no anomalies related to the reported failure.The reported complaint was not confirmed.

Manufacturer Narrative

Unique device identifier (udi): (b)(4).Device history record (dhr) - the dhr was reviewed and found no anomaly during its manufacturing, packaging, and inspection processes that could be related to the ¿leakage¿ condition of device.The fg lot met all in-process inspections and testing requirements as specified in the shop order and related procedures.The reported condition of ¿leak¿ could be confirmed with the evaluation of the returned excel 23khx tubing set.The evaluation identified that the irrigation tube (with blue strip) was damaged and cracked.The cusa excel user¿s guide provides the proper instructions for the tubing assembly into the console machine and also indicate 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 root cause of the reported condition is related to an improper assembly of the tube into the console machine.The complaint investigation discards any relationship of the reported condition with the product manufacturing processes at integra.

Event Description

N/a.

• Brand Name: EXCEL 23KHZ TUBING SET BOX6
• 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: 10530373
• MDR Text Key: 206824849
• Report Number: 3006697299-2020-00102
• 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,Followup
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: C3600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR