MAUDE Adverse Event Report: STRYKER CORPORATION STRYKEFLOW; LAPAROSCOPE, GENERAL PLASTIC SURGERY

Model Number 0250070500

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/17/2020

Event Type  malfunction  

Event Description

Suction irrigator was spiked with a 1l nacl bag.While surgeon was inserting ports into patient they noticed black stuff on sterile drapes that was coming from the bottom of the suction irrigator that holds batteries.Patient was re-draped and new suction irrigator was obtained and used.

• Brand Name: STRYKEFLOW
• Type of Device: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): STRYKER CORPORATION; 4100 east milham ave.; kalamazoo MI 49001
• MDR Report Key: 10372437
• MDR Text Key: 201860360
• Report Number: 10372437
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 07613327061390
• UDI-Public: (01)07613327061390(17)211123(10)19328FG2
• 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: 07/22/2020

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: No Information
• Device Model Number: 0250070500
• Device Catalogue Number: 250-070-500
• Device Lot Number: 19328FG2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/22/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/06/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1