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

Catalog Number 250-070-520

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

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

Event Date 11/01/2021

Event Type  malfunction  

Event Description

Robot-assisted laparoscopic sleeve gastrectomy performed.During surgery fluid noted to be leaking from suction irrigator.At the conclusion of surgery, staff opened battery compartment / pump housing and noted batteries had corrosion present.Pt is stable.

• Brand Name: STRYKER SUCTION IRRGATOR
• Type of Device: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): STRYKER ENDOSCOPY; 5900 optical court; san jose CA 95138
• MDR Report Key: 12750953
• MDR Text Key: 280459034
• Report Number: MW5105118
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 07613327061369
• UDI-Public: 07613327061369
• 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: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2023
• Device Catalogue Number: 250-070-520
• Device Lot Number: 21215FG2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 23 YR
• Patient Sex: Female
• Patient Weight: 106 KG
• Patient Race: Black Or African American