MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR CUSA EXCEL 23KHZ CEM NOSECONE ; ULTRASONIC SURGICAL PRODUCTS

Catalog Number C6623

Device Problems Sticking (1597); Failure to Shut Off (2939)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/19/2015

Event Type  malfunction  

Event Description

The second report of two involving the same product c6623 cusa excel cem 23khz nosecone and the same pt.(mfr.Report number 3006697299-2015-00048 pr 125859).It was reported that the diathermy continued after the button was released during an open hepatectomy-- so therefore notable sticking.There were 2 nosecones with the same issue during the 1 procedure- lot# 1140146 x 1; lot# 1141946 x 1.Delay to surgery approx 20 minutes while they changed over nosecones.No adverse pt outcomes were reported.The sales rep stated that this surgeon/hosp are still aware of the issue about changing over the nosecone after 30 minutes as per ifu instructions.Sales rep noted that it was a difficult case that was prolonged and diathermy was on for more than 30 minutes.

Manufacturer Narrative

To date, the device involved in the reported incident has not been received for eval.An investigation has been initiated based upon the reported info.

Manufacturer Narrative

Integra completed its internal investigation 8/31/2015.The investigation included: method: dhr review.Complaint trend.Visual inspection.Results: manufacturing dates: lot: 1140146 - 2/8/2014.Lot: 1141946 - 6/29/2014.The dhrs of the fg lots # 1140146 and 1141946 were reviewed as part of this investigation.The fg lots were released for distribution purpose in compliance with the product specifications and quality system requirements.A two year look back for this reported failure and or related to "diathermy continued after button released" for this product id shows that (b)(4) complaints were received including this case.A capa was issued to further investigate this reported failure.Conclusion: reported failure could not be confirmed or reproduced.However the button did not activate cem when pushed, which does indicate a possible issue with the switch.Leakage current was below the acceptable level of 2000mo (read 1.5mo), which may be due to a breakdown in the insulating property of the switch/activation mechanism of the nosecone, as opposed to another part of the cem circuit.Additionally, the switch circuit was reading greater than 2mo (read 11.4mo), which indicates an open circuit condition in the cem switch.Buildup of white material was noticed in the switch, which does not allow switch to press down properly and may be indicative of material migration.

• Brand Name: CUSA EXCEL 23KHZ CEM NOSECONE
• Type of Device: ULTRASONIC SURGICAL PRODUCTS
• Manufacturer (Section D): INTEGRA NEUROSCIENCES PR ; anasco PR 00610
• Manufacturer (Section G): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; anasco PR 00610
• Manufacturer Contact: linda serentino ; 311 enterprise drive; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 4692960
• MDR Text Key: 19986258
• Report Number: 3006697299-2015-00049
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K141674
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C6623
• Device Lot Number: 1140146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 60 YR