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 04/19/2021

Event Type  malfunction  

Event Description

A patient with history of hypertension, post-menopaused bleeding and uterine fibroids was admitted to the operating room for a robotic assisted total laparoscopic hysterectomy.The stryker strykeflow disposable suction/irrigator was opened for the procedure.With close observation, there is white substance in the tubing.Product was not used, another one was used in its place.No harm to patient.This is device #21 when packages of products examined and include only 2 lot numbers.All pics and lot numbers provided in pictures.Please refer to medsun report 3600840000-2021-8056 previously reported.

• 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: 11736966
• MDR Text Key: 247889942
• Report Number: 11736966
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 07613327061369
• UDI-Public: (01)07613327061369(17)230208(10)21039FG2
• 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: 04/20/2021

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: Other
• Device Model Number: 0250070520
• Device Catalogue Number: 250-070-520
• Device Lot Number: 21039FG2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/20/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/28/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25550 DA
• Patient Weight: 107