MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA CLARITY 36KHZ CURVED EXTENDED MICROTIP PLUS (SINGLE PACK)

Catalog Number C7415SEA

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/07/2021

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A physician reported that during nasal endoscopic surgery, the cusa clarity 36khz curved extended microtip (c7415sea) was chipped (root side from the pre-aspiration hole), and when it was returned to the surgical field, the tip was chipped and fell into the surgical field.An intraoperative x-ray was taken and they succeeded in picking up the missing tip.Another unspecified product was used for the procedure, and the surgical time was extended for less than 30 minutes.Additional information received stated that the perfusion flow rate was changed along with the change in amplifier which was used between 5 and 15 ml/min.

Manufacturer Narrative

Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10.Cusa clarity 36khz curved extended microtip¿ plus (c7415sea) was returned for evaluation: device history record (dhr): the dhr was reviewed according to the complaint information that the ¿tip was chipped¿ or ¿broken tip¿; however, no anomaly was observed that could be related to the reported condition.Failure analysis - the reported complaint was confirmed.Evaluation of the returned tip confirmed that it was in fact fractured.Root cause - the root cause is most likely that one or more of the following warnings in the cusa excel ifu and user guide were not avoided: ¿ when the handpiece is powered on, contact of the tip with a hard surface (for example: a metal instrument, tray, staples, clips, instruments, and so on) may damage the tip of the handpiece and require replacement before use.¿ avoid excessive lateral loading of cusa excel tips.This may result in injury to the patient and/or user, or equipment damage.¿ avoid contacting bone with the cusa excel tips.¿ when testing the handpiece, do not allow the tip to come in contact with any person or object during tip activation.Contact may result in injury to the patient and/or user, or handpiece tip damage.¿ turning the torque wrench further clockwise will damage the handpiece.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

Event Description

N/a.

• Brand Name: CUSA CLARITY 36KHZ CURVED EXTENDED MICROTIP PLUS (SINGLE PACK)
• Type of Device: CUSA CLARITY
• Manufacturer (Section D): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; ida business&technology park; sragh, tullamore, co.offaly ; EI
• MDR Report Key: 12271141
• MDR Text Key: 264985872
• Report Number: 3006697299-2021-00027
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• PMA/PMN Number: K161882
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: C7415SEA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Date Manufacturer Received: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1