MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., AGG. PLUS SHAVER BLADE, F- SERIES - 4.0MM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number 0375544000

Device Problem Insufficient Information (3190)

Patient Problem Burn, Thermal (2530)

Event Date 01/09/2018

Event Type  Injury  

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.Gtin: (b)(4).

Event Description

It was reported that the shaver burned the patient.

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: shaver started smoking, was extremely hot.Burned patient.Salesforce case number (b)(4).The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root cause could be user excessive force.( per the visual inspection , it is possible that the product was used under high load near the proximal end which caused contact between assemblies and made the shaft break.Further more it could have caused friction leading the shave blade to heat to abnormal temperature) the device manufacture date is not known.(b)(4).

Event Description

It was reported that the shaver burned the patient.

• Brand Name: PKG., AGG. PLUS SHAVER BLADE, F- SERIES - 4.0MM
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• 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: ashley lower ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 7243056
• MDR Text Key: 99068900
• Report Number: 0002936485-2018-00092
• Device Sequence Number: 1
• Product Code: GFA
• 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: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0375544000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other