MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 4MM 30° C-MOUNT STYLE A ARTHROSCOPE

Catalog Number 0502427030

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 07/07/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was alleged that the patient was burned.Further information confirmed that there was no surgical delay or medical intervention.

Manufacturer Narrative

The product was not returned for investigation therefore the reported failure mode was not confirmed.Alleged failure: patient burned.Probable root cause: too much light from light source.Light source left on and scope/adapter left on or in patient.Reflected laser energy to the scope when used with laser equipment.Electrical discharge or coupled hf current when used with hf surgical equipment.The failure mode will be monitored for future reoccurrence.Mfg date: manufacture date is not known since the serial / lot number was not provided and the device was not received.(b)(4).

Event Description

It was alleged that the patient was burned.Further information confirmed that there was no surgical delay or medical intervention.

• Brand Name: 4MM 30° C-MOUNT STYLE A ARTHROSCOPE
• Type of Device: ARTHROSCOPE
• 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: 5837923
• MDR Text Key: 50904725
• Report Number: 0002936485-2016-00708
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093677
• 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: 07/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0502427030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2016
• 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
• Patient Outcome(s): Other