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

Model Number 0250070500

Device Problems Fluid/Blood Leak (1250); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2019

Event Type  malfunction  

Event Description

Irrigation tubing comes apart from the battery pack causing intravenous fluid to leak over the battery pack.There was no harm to any patient or provider.Manufacturer response for laparoscope, general plastic surgery, strykeflow (per site reporter).They would like to learn of the failure and investigate.

• Brand Name: STRYKEFLOW
• Type of Device: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY; 5900 optical ct; san jose CA 95138
• MDR Report Key: 9201996
• MDR Text Key: 162634926
• Report Number: 9201996
• Device Sequence Number: 1
• Product Code: GCJ
• 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: 10/15/2019

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: 0250070500
• Device Catalogue Number: 250-070-500
• Device Lot Number: 19141FG2
• 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: 10/15/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 13140 DA