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

Model Number 0250070620

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 03/17/2021

Event Type  malfunction  

Event Description

An ahto suction/irrigator tube set developed a leak around the pump housing during surgery.The device had been used to irrigate as well as suction prior to the leak being noticed.

• Brand Name: AHTO
• Type of Device: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical court; san jose CA 95138
• MDR Report Key: 11841002
• MDR Text Key: 251167672
• Report Number: 11841002
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 07613327061659
• UDI-Public: (01)07613327061659
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 0250070620
• Device Catalogue Number: 250-070-620
• Device Lot Number: 20301FG2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/06/2021
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27010 DA