MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LTD. CUSA EXCEL 23KHZ LAPAROSCOPIC TIP ELT; ULTRASONIC SURGICAL PRODUCTS

Catalog Number C4604ELT

Device Problems Loss of or Failure to Bond (1068); Disconnection (1171); Loose or Intermittent Connection (1371)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/17/2016

Event Type  malfunction  

Event Description

During use of the device for a laparoscopic hepatectomy, the gold and the silver piece of the tip came loose and were disconnected.It was confirmed that the tip was torqued properly.There was no health problem or injury caused by this incident.Additional information was received from the distributor on 13jul2016: during surgery, the user found an error in handpiece amplitude.When it was checked, the tip was coming loose.The product was not used on the patient.Patient age and gender unknown.After the issue occurred, they stopped using the tip.There was about an hour surgery delay due to the issue but there was no patient adverse consequence as a result of the delay.

Manufacturer Narrative

Integra has completed their internal investigation on 14 oct 2016.The investigation included: methods: -evaluation of actual device.-review of device history records.-review of complaint history.Results: evaluation of device: visual inspection under magnification: scratches were observed along the length of each section consistent with contact to another hard object or instrument.Note that the scratches are not severe enough to have caused or contributed to the tip separation.Inspection of threads on each section found no abnormalities or evident defects.There was no evidence found to suggest that a tool such as vice-grips was utilized to separate the two sections.This lot was manufactured in the (b)(4) facility which was closed at the end of june 2015.The manufacturing process was transferred to (b)(4).Device history record reviewed for this product id lot manufactured on february 02, 2015 show no abnormalities related to the reported failure.This device passed all required inspection points with no associated mrr¿s, variances or rework.A two year look back in trackwise for this reported failure and or related to "silver piece and gold piece coming loose" for this product id shows that 4 complaints were received including this case.No new design or manufacturing trends have been identified.This issue will be monitored.Conclusion: the failure mode is considered a manufacturing process defect.The reported complaint was confirmed.A visual inspection of the returned c4604elt excel 23khz laparoscopic tip found no visible, physical damage.Inspection of the locking threads found no abnormalities.Given that the manufacturing facility has been closed and the process re-validated upon transfer, the root cause cannot be conclusively determined.Complaints will continue to be monitored for trends to determine if further action is needed.

• Brand Name: CUSA EXCEL 23KHZ LAPAROSCOPIC TIP ELT
• 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: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5807197
• MDR Text Key: 50733082
• Report Number: 3006697299-2016-00158
• 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: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/01/2016

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: C4604ELT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/01/2016
• Initial Date FDA Received: 07/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2015
• 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