MAUDE Adverse Event Report:; GENERAL SURGERY TRAY

; GENERAL SURGERY TRAY

Device Problem Break (1069)

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

Event Date 11/11/2019

Event Type malfunction

Event Description

Surgical pack with device was opened in operating room.Device was found to be broken and thus was not used during surgery.

1 Device was Involved in the Event
Type of Device	GENERAL SURGERY TRAY
MDR Report Key	9782945
MDR Text Key	181968473
Report Number	9782945
Device Sequence Number	1
Product Code	LRO
Combination Product (y/n)	N
Number of Events Reported	1
Summary Report (Y/N)	N
Report Source	User Facility
Reporter Occupation	Risk Manager
Type of Report	Initial
Report Date	11/22/2019
1 Patient was Involved in the Event
Date FDA Received	03/03/2020
Is this an Adverse Event Report?	No
Is this a Product Problem Report?	Yes
Device Operator	No Information
Was Device Available for Evaluation?	Device Returned to Manufacturer
Date Returned to Manufacturer	11/18/2019
Is the Reporter a Health Professional?	No
Was the Report Sent to FDA?	Yes
Date Report Sent to FDA	11/22/2019
Device Age	3 MO
Event Location	Hospital
Date Report to Manufacturer	03/03/2020
Is This a Reprocessed and Reused Single-Use Device?	No
Type of Device Usage	N
Patient Sequence Number	1
Patient Age	27740 DA
Patient Weight	25