MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 4MM A/C CANNULA, 1 ROTATING STOPCOCK W/ SPEEDLOCK(HIGH FLOW); ACCESSORIES,ARTHROSCOPIC

Catalog Number 0502244530

Device Problem Compatibility Problem (2960)

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

Event Date 06/07/2016

Event Type  malfunction  

Manufacturer Narrative

The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.(b)(4).

Event Description

It was reported that the scope was too short for the cannula.The surgeon could unintentionally scoop out small portions of cartilage.

Manufacturer Narrative

The product was not returned for investigation therefore the reported failure mode was not confirmed.Scope too short for cannula.Probable root cause: manufacturing error.The failure mode will be monitored for future reoccurrence.(b)(4).

Event Description

It was reported that the scope was too short for the cannula.The surgeon could unintentionally scoop out small portions of cartilage.

• Brand Name: 4MM A/C CANNULA, 1 ROTATING STOPCOCK W/ SPEEDLOCK(HIGH FLOW)
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: kimberly lynch ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 5762406
• MDR Text Key: 48862116
• Report Number: 0002936485-2016-00601
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0502244530
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1