MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PACKAGING, FORMULA SHAVER (HAND CONTROL); BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	0375704500
Medical Device Problem Code	Insufficient Cooling (1130)
Health Effect - Clinical Codes	Burn(s) (1757); Burn, Thermal (2530)
Date of Event	11/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
Event or Problem Description
It was reported that the patient was burned.
Additional Manufacturer Narrative
Alleged failure: shaver over heating burned salesforce case number (b)(4).Harm: burned pt.Delay: 5m.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root causes could be 1) excessive force applied to the cutter/burr by the user with poor or no suction during use.(excessive force may cause friction due to bur shaft assembly and housing assembly interaction.) (2) tissue blocking the suction pathway would prevent hot fluid from being removed from the joint.(3) poor arthroscopy pump suction.(4) additionally, during arthroscopic procedures, it is common to use an rf energy wand.Inherent to use of an rf probe is the risk of potential superficial patient burns due to the heat generated from the rf output.Therefore use of the rf probe can also be considered a possible root cause as well.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.
Event or Problem Description
It was reported that the patient was burned.

• Brand Name: PACKAGING, FORMULA SHAVER (HAND CONTROL)
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10936986
• Report Number: 0002936485-2020-00503
• Device Sequence Number: 702565
• Product Code: GFA
• UDI-Device Identifier: 07613327057638
• UDI-Public: 07613327057638
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0375704500
• Device Catalogue Number: 0375704500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Initial Date Received by Manufacturer: 11/05/2020
• Supplement Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 01/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other