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

Model Number 0375704500

Device Problems Insufficient Cooling (1130); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Burn, Thermal (2530)

Event Date 11/05/2020

Event Type  malfunction  

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 Description

It was reported that the patient was burned.

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 Description

It was reported that the patient was burned.

• Brand Name: PACKAGING, FORMULA SHAVER (HAND CONTROL)
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10936986
• MDR Text Key: 219297861
• Report Number: 0002936485-2020-00503
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 07613327057638
• UDI-Public: 07613327057638
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other