MAUDE Adverse Event Report: STRYKER ENDOSCOPY STRYKER COBRA; ACCESSORIES, ARTHROSCOPIC

Model Number 3910-900-093

Device Problem Product Quality Problem (1506)

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

Event Date 03/17/2020

Event Type  malfunction  

Event Description

This medical device has the potential to "stick" an employee.The sharp tip that is hidden has historically been classified as a "sharp".Very unsafe device for healthcare personnel.Fda safety report id# (b)(4).

• Brand Name: STRYKER COBRA
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY
• MDR Report Key: 9853351
• MDR Text Key: 184482206
• Report Number: MW5093840
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 07613327413595
• UDI-Public: (01)07613327413595
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3910-900-093
• Device Catalogue Number: 3910-900-093
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/17/2020
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1