MAUDE Adverse Event Report: GYRUS ACMI, INC DIEGO TRIGGER ENABLED HANDPIECE; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Model Number	70339001
Medical Device Problem Codes	Corroded (1131); Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reports during an unspecified procedure using a dca1401 handpiece, the hand piece overheated and the patient experienced a burn.No further details are known.Multiple attempts to obtain additional details regarding the patient and reported event have been made.At this time, no additional information has been provided.
Additional Manufacturer Narrative
The device referenced in this report has not bee returned to olympus for evaluation (although it is anticipated).The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Additional Manufacturer Narrative
This report is being updated to provide investigation findings.The device was returned.Upon evaluation, the device was noted for heavy corrosion located on the inner housing where the disposables are inserted and also on the inside of one of the ports.The handpiece appeared to have no missing components, as all four bearings are still intact.The housing has minor scratches and the cable appears to have no kinks.There were no other abnormalities noted in the visual inspection.The original equipment manufacturer (oem) performed a device history record review and no abnormalities were noted.This product with was manufactured within specification on 27jan2020.An investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.The root cause has been determined to be user error as the phenomenon could not be replicated when temperature tested three times per the evaluation results.The handpiece was tested by olympus using the default setting of 5000rpm for 5 continuous minutes each interval.The results ranged from 93 degrees fahrenheit to 96 degrees fahrenheit, which is within 105 degree fahrenheit specification.Customer phenomenon of the handpiece overheating was not confirmed.The over heating of the handpiece could have occurred if the device was used outside specifications for time intervals and rpm.

• Brand Name: DIEGO TRIGGER ENABLED HANDPIECE
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: kenneth pittman ; 118 turnpike road; southborough, MA 01772 ; 9013785969
• MDR Report Key: 12872273
• Report Number: 3003790304-2021-00175
• Device Sequence Number: 4509488
• Product Code: ERL
• UDI-Device Identifier: 00821925011410
• UDI-Public: 00821925011410
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K020594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 70339001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2021
• Supplement Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 12/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown