MAUDE Adverse Event Report: STRYKER CORPORATION STRYKEFLOW; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number 0250070520

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/12/2021

Event Type  malfunction  

Event Description

A (b)(6) patient with history of diabetes mellitus and hypertension was admitted to the or for procedure robotic assisted total lab hysterectomy, bilateral salpingooophorectomy, lysis of adhesions and cystoscopy.When opening the sterile package with the strykeflow disposable suction/irrigator with disposable tip, the tubing portion has a white, paste-like material in some areas.Product not used, another one obtained.

Event Description

A patient with history of diabetes mellitus and hypertension was admitted to the or for procedure robotic assisted total lab hysterectomy, bilateral salpingooophorectomy, lysis of adhesions and cystoscopy.When opening the sterile package with the strykeflow disposable suction/irrigator with disposable tip, the tubing portion has a white, paste-like material in some areas.Product not used, another one obtained.

• Brand Name: STRYKEFLOW
• Type of Device: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical ct; san jose CA 95138
• MDR Report Key: 11692734
• MDR Text Key: 246265948
• Report Number: 11692734
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 07613327061369
• UDI-Public: (01)07613327061369(17)230124(10)21024FG2
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0250070520
• Device Catalogue Number: 250-070-520
• Device Lot Number: 21024FG2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/13/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/20/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/20/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 17520 DA
• Patient Weight: 78