MAUDE Adverse Event Report: GYRUS ACMI, INC DIEGO STR. VIPER HANDPIECE

Model Number	70338020
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was received and evaluated.The handpiece was visually inspected for abnormalities.The reported issue was confirmed, the handpiece was found to have a cut on the cord, as well as cosmetic wear and tear.Moreover, functional tests were performed to assess the device status.There were no discernible damages discovered.The definitive root cause of the cord damages can be attributed to customer use or transportation.Per the surgical drill systems department functional checklist, the device was checked for physical damages at the power cord to ensure that it is free from cuts, buckles, or kinks.The device history record review found that the device was manufactured without ncrs (non conformances) , reported scrap or recorded process deviations relating to the reported failure.Therefore, it is likely the device left the facility without damages to the power cord.Olympus will continue to monitor complaints for this device.
Event or Problem Description
As reported, the device cord that attached to the drill was found with a cut.The issue found during reprocessing.There was no patient involvement associated on this reported event.No user injury reported.

• Brand Name: DIEGO STR. VIPER HANDPIECE
• Common Device Name: DIEGO STR. VIPER HANDPIECE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 12734112
• Report Number: 1037007-2021-00050
• Device Sequence Number: 14592076
• Product Code: ERL
• UDI-Device Identifier: 00821925011465
• UDI-Public: 00821925011465
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K992994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 70338020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 11/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1