MAUDE Adverse Event Report: STRYKER ENDOSCOPY FORMULA; BUR, SURGICAL

Model Number 375-562-000

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 06/09/2014

Event Type  No Answer Provided  

Event Description

While the device was being used the port was at 60 degrees and came in contact with the patient's skin and caused a superficial burn.

• Brand Name: FORMULA
• Type of Device: BUR, SURGICAL
• Manufacturer (Section D): STRYKER ENDOSCOPY; 5900 optical court; san jose CA 95138
• MDR Report Key: 3940506
• MDR Text Key: 4577736
• Report Number: 3940506
• Device Sequence Number: 1
• Product Code: HTT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/12/2014

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?: *
• Device Operator: Physician
• Device Model Number: 375-562-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/12/2014
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 07/17/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/12/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 105