MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE UNKNOWN_ENDOSCOPY_PRODUCT; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number UNK_END

Device Problem Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 08/20/2018

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 and pma/510(k)# are unknown because the catalog # is unknown.If the catalog # is confirmed, it will be supplied in the final report.

Event Description

It was reported that the devices overheated and caused a burn to the patient.

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: "the customer reported that during an ankle arthroscopy, overheating of formula shaver occurred (burr consumable used) and the surgeon used a wet swab to continue using.He then changed to a new shaver hand piece which also overheated.The patient has suffered burns around the ankle area.The customer further reported that the burn is to lateral aspect of incision and that the patient undergoing some form of plastic surgery to rectify it." 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.Or (3) poor arthroscopy pump suction.The probable root cause for cable assembly failed hi-pot test is the cable assembly.

Event Description

It was reported that the devices overheated and caused a burn to the patient.

• Brand Name: UNKNOWN_ENDOSCOPY_PRODUCT
• Type of Device: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8251287
• MDR Text Key: 133182323
• Report Number: 0002936485-2019-00022
• Device Sequence Number: 1
• Product Code: GFF
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/20/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_END
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Initial Date Manufacturer Received: 01/07/2019
• Initial Date FDA Received: 01/15/2019
• Supplement Dates Manufacturer Received: 01/07/2019
• Supplement Dates FDA Received: 05/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other