MAUDE Adverse Event Report: STRYKER CORP. STRYKER SUCTION / IRRIGATOR; APPARATUS, SUCTION, OPERATING -ROOM, WALL VACUUM POWERED

Catalog Number 250-070-520

Device Problem Material Separation (1562)

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

Event Date 12/21/2018

Event Type  malfunction  

Event Description

Pt in surgery and a stryker suction / irrigator came apart from the white base when hooking up saline bag.Equipment removed.New equipment obtained.Will monitor the usage of this equipment to see if this occurs again.To track and trend.No harm to the pt.

• Brand Name: STRYKER SUCTION / IRRIGATOR
• Type of Device: APPARATUS, SUCTION, OPERATING -ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): STRYKER CORP.
• MDR Report Key: 8203122
• MDR Text Key: 131897442
• Report Number: MW5082668
• Device Sequence Number: 1
• Product Code: GCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2020
• Device Catalogue Number: 250-070-520
• Device Lot Number: 18330FG2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 83