MAUDE Adverse Event Report: STRYKER ENDOSCOPY STRYKEFLOW2 SUCTION IRRIGATOR; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number PN 250-070-500

Device Problems Corroded (1131); Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 03/16/2022

Event Type  Injury  

Event Description

From surgeon's op note: at this point, the suction irrigator refluxed some fluid into the abdomen.It turned out that the irrigator was broken and this was replaced.The area was thoroughly irrigated, hemostasis was achieved.The ureter on the left side was reinspected.Tisseel was sprayed over the retroperitoneal surfaces.The abdomen was desufflated.The ports were removed and irrigated and closed with 4-0 vicryl in subcuticular fashion.Dermabond was applied.The patient was awakened from anesthesia and taken to the recovery room in good condition.From staff: while using the disposable laparoscopic stryker suction irrigator the circulating rn noticed brown fluid leaking onto the floor.Upon investigation we noticed that the suction irrigator battery pack was leaking water/ brown fluid out of it.At this same time, the surgeon noticed a brown liquid substance inside the patients abdomen after irrigating with device.The circulating rn immediately stopped the team from using the device and called a supervisor, notified surgeon, and replaced the saline and suction irrigator device.The surgeon copiously irrigating the patients abdomen.On opening the battery pack on the device, it was found to have water, brown liquid, and corrosion on batteries.Supervisor took pictures of device and placed device and original packaging in biohazard bag and labeled with the patients sticker.Supervisor notified materials management and all suction irrigator devices with some lot number were immediately removed from the operating room.Vendor and infection prevention also notified.Fda safety report id# (b)(4).

• Brand Name: STRYKEFLOW2 SUCTION IRRIGATOR
• Type of Device: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): STRYKER ENDOSCOPY
• MDR Report Key: 13847224
• MDR Text Key: 287692517
• Report Number: MW5108379
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2023
• Device Model Number: PN 250-070-500
• Device Lot Number: 21324FG2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White