MAUDE Adverse Event Report: STRYKER ENDOSCOPY BATTERY OPERATED SUCTION IRRIGATOR; APPARATUS, SUCTION, OPERATING ROOM, WALL VACUUM POUDRE

Catalog Number 250-070-500

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 04/24/2018

Event Type  malfunction  

Event Description

On (b)(6) 2018 a nurse spiked a 1000ml b-braun saline iv bag with a stryker battery operated suction irrigator.The nurse noticed that there was a black foreign material floating inside of the saline bag.Since the origin of the substance could not be determined, both the saline bag and irrigator were removed from the field, along with all products with corresponding lot numbers.After collection of all bags, the company was notified immediately.There were approx 400 affected bags."is the product compounded: yes, is the product over-the-counter: no.".

• Brand Name: BATTERY OPERATED SUCTION IRRIGATOR
• Type of Device: APPARATUS, SUCTION, OPERATING ROOM, WALL VACUUM POUDRE
• Manufacturer (Section D): STRYKER ENDOSCOPY
• MDR Report Key: 7529723
• MDR Text Key: 108895671
• Report Number: MW5077328
• Device Sequence Number: 2
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/14/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 250-070-500
• Device Lot Number: 18064FG2
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/18/2018
• 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