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

Model Number 0250070520

Device Problems Crack (1135); Leak/Splash (1354)

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

Event Date 03/22/2023

Event Type  malfunction  

Event Description

Informed by circulating rn that disposable suction irrigator had been leaking fluid from battery motor compartment.No harm to the patient.Believe there was a crack in the device cracked.

• Brand Name: STRYKEFLOW
• Type of Device: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): STRYKER INSTRUMENTS; 1941 stryker way; portage MI 49002
• MDR Report Key: 16701105
• MDR Text Key: 312883979
• Report Number: 16701105
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 07613327061369
• UDI-Public: (01)07613327061369
• 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: 03/23/2023

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: 23012FG2
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/23/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/07/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/07/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22265 DA
• Patient Sex: Female