MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE FORMULA SHAVER HANDPIECE (NO BUTTONS); ACCESSORIES, ARTHROSCOPIC

Catalog Number 0375701500

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 09/26/2014

Event Type  Injury  

Event Description

It was reported that the unit overheated and caused a slight burn to the patient's shoulder.

Manufacturer Narrative

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

Manufacturer Narrative

The reported device was not received for investigation; therefore, the reported failure cannot be confirmed.The complaint will be closed without a detailed investigation report and based on probable root cause.In the event that the device is received, the complaint will be reopened, a full evaluation will be conducted, and the investigation will be updated with the new results.Probable root cause for the reported failure involving this device could have been caused by: material/design error; user misuse or overuse; manufacturing/assembly error.In sum, the reported failure could not be confirmed since the device was not received at stryker endoscopy for investigation in sum, the product was not returned and the failure mode was not confirmed.

Event Description

It was reported that the unit overheated and caused a slight burn to the patient's shoulder.

• Brand Name: FORMULA SHAVER HANDPIECE (NO BUTTONS)
• 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: thomas shafer ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 4215965
• MDR Text Key: 5039554
• Report Number: 0002936485-2014-00861
• 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: 10/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0375701500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/10/2014
• Initial Date FDA Received: 10/30/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/12/2014
• 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