MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) EXCEL 36KHZ STRAIGHT HANDPIECE EACH1; ULTRASONIC SURGICAL PRODUCTS

Catalog Number C2602

Device Problem Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 07/09/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not yet returned to the manufacturer for analysis.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 c2602 excel 36khz straight handpiece was rejected during their incoming inspection of goods because when using the handpiece with the c4610s tip, a vibration alarm occurred with the test mode on (b)(6) 2019.Additional information has been received on 08aug2019 that there was no required revision or medical intervention.

Manufacturer Narrative

Udi#: (b)(4).The device was returned for evaluation.The technician found that the handpiece had a faulty transducer - delamination the dhr was reviewed and no anomalies that could be associated with the complaint incident was observed.No service history for the device under evaluation.The complaint was verified as valid.

Event Description

N/a.

• Brand Name: EXCEL 36KHZ STRAIGHT HANDPIECE EACH1
• 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: 8930456
• MDR Text Key: 195162622
• Report Number: 3006697299-2019-00100
• 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: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: C2602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Date Manufacturer Received: 10/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: C4610S TIP