MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP UNKNOWN_INSTRUMENTS_PRODUCT; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number UNK_INS

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 07/06/2018

Event Type  Injury  

Manufacturer Narrative

H6: a follow up report will be filed once the quality investigation is complete.H3 other text : device not available for return.

Event Description

It was reported that during a meningioma case the patient¿s artery was damaged while attempting to debulk the tumor, which required unanticipated vessel repair.It was further alleged that the tip of the sonopet device was not visible to the surgeon under the operating microscope and that the tissue ablation properties were inadequate therefore considerable force was required to debulk the tumor.No device malfunction was reported.

Event Description

It was reported that during a meningioma case the patient¿s artery was damaged while attempting to debulk the tumor, which required unanticipated vessel repair.It was further alleged that the tip of the sonopet device was not visible to the surgeon under the operating microscope and that the tissue ablation properties were inadequate therefore considerable force was required to debulk the tumor.No device malfunction was reported.

Manufacturer Narrative

Correction b1: adverse event and product problem.Correction f10/h6: use of device problem.H6: the quality investigation is complete.

• Brand Name: UNKNOWN_INSTRUMENTS_PRODUCT
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• Manufacturer Contact: colette chung ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 18141803
• MDR Text Key: 328187340
• Report Number: 3015967359-2023-02471
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_INS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention