MAUDE Adverse Event Report: INTEGRA YORK, PA INC. YARARGIL MICRO DISSECTOR BAYO 7-1/4 ARACHNOID; MICRO DISSECTORS

Catalog Number RB9344

Device Problem Break (1069)

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

Event Date 02/15/2018

Event Type  malfunction  

Manufacturer Narrative

Root cause cannot be determined due to the lack of information received to perform a complete investigation.There has been no manufacturing deficiency identified, the instrument has not been returned for evaluation.Linked manufacturing numbers: 2523190-2018-00038 and 2523190-2018-00037.

Event Description

A customer reported on (b)(6) 2018, the stardust dnh str #278093, spring¿s handle suddenly broke while the surgeon was suturing the patient.Also during use suspect device, rb9344 yarargil micro dissector bayo, tip broke and fell in the patient¿s brain cavity.The surgeon retrieved the broken tip from the patient.It was noted there was a 15-minute delay of the surgery.The surgery was completed with other instruments and the patient was fine.This is one of two reports concerning the same patient and procedure using two integra devices.

Manufacturer Narrative

Investigation completed on 08mar2018.There were pictures supplied showing that the tip is bent.The complaint report of damage has been confirmed; the root cause of the damage has not been identified as a workmanship or material deficiency.

• Brand Name: YARARGIL MICRO DISSECTOR BAYO 7-1/4 ARACHNOID
• Type of Device: MICRO DISSECTORS
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• MDR Report Key: 7364097
• MDR Text Key: 103531904
• Report Number: 2523190-2018-00037
• Device Sequence Number: 1
• Product Code: GZX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RB9344
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR