MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE FORMULA SHAVER HANDPIECE (WITH BUTTONS); BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number 0375704500

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2015

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Event Description

It was reported that the handpiece got hot during usage.It was alleged that the current was too high.Although there was patient involvement, there was no patient impact.

Manufacturer Narrative

Visual inspection: no physical damage observed throughout the handpiece or cable.Functional inspection: the handpiece in question was set up for testing using the following fixtures: tube set, pump, crossfire, and blade.Also, a joint fixture and water source were included in the testing.The handpiece was then activated several times with suction lever set to open.After several activations, the handpiece did not get hot to the touch.(b)(4).The probable root cause for the reported failure involving this device could be due to a failed motor.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.

Event Description

It was reported that the handpiece got hot during usage.It was alleged that the current was too high.Although there was patient involvement, there was no patient impact.

• Brand Name: FORMULA SHAVER HANDPIECE (WITH BUTTONS)
• Type of Device: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• 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: 5164117
• MDR Text Key: 29216300
• Report Number: 0002936485-2015-00931
• Device Sequence Number: 1
• Product Code: GFF
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/24/2015

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0375704500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2015
• Initial Date FDA Received: 10/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2015
• 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