MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA EXCEL 36KHZ CEM NOSECONE; ULTRASONIC SURGICAL PRODUCTS

Catalog Number C6636

Device Problems Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 05/24/2019

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

A distributor reported that the c6636 cusa excel 36khz cem nosecone was rejected during an incoming inspection because of damaged individual package and foreign material found.The device was not in contact with the patient and no alleged patient injury was reported.

Manufacturer Narrative

The product was not sent in to the manufacturer for evaluation.Device history record (dhr) of finished goods was reviewed and showed no anomaly was reported in this fg lot during its packaging and inspection processes that could be related to the reported conditions of ¿damaged individual package¿ and ¿foreign material¿.The lot met all in-process inspections and testing requirements as specified in the packaging shop order and related procedures.The reported condition was unconfirmed.The root cause was undetermined at this time.Device identifier #: (b)(4).

Event Description

N/a.

• Brand Name: CUSA EXCEL 36KHZ CEM NOSECONE
• 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: 8735151
• MDR Text Key: 150850847
• Report Number: 3006697299-2019-00070
• 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
• Type of Report: Initial,Followup
• Report Date: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: C6636
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1