MAUDE Adverse Event Report: STRYKER ENDOSCOPY STRYKER ARTHROSCOPIC SHAVER; ARTHROSCOPIC SHAVER BLADE

Catalog Number 0375-544-000

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 09/04/2018

Event Type  malfunction  

Event Description

Staff opened a brand new arthroscopic shaver and while taking it out of the cannula, fluid came out.The device was not used on the patient, it was caught prior to start of the case.Manufacturer response for arthroscopic shaver blade, stryker (per site reporter).Nothing as of now.

• Brand Name: STRYKER ARTHROSCOPIC SHAVER
• Type of Device: ARTHROSCOPIC SHAVER BLADE
• Manufacturer (Section D): STRYKER ENDOSCOPY; 5900 optical court; san jose CA 95138
• MDR Report Key: 7872101
• MDR Text Key: 120106610
• Report Number: 7872101
• Device Sequence Number: 1
• Product Code: GFA
• 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: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0375-544-000
• Device Lot Number: 18113CE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/04/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 12775 DA
• Patient Weight: 25