MAUDE Adverse Event Report: GYRUS ACMI, INC BIPOLAR, 4MM 40DEG, STANDARD, SERRATED, DS, 5/PK; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	BB4040SS
Medical Device Problem Codes	Mechanical Problem (1384); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during removal of polyps in the paranasal sinus procedure , white insulation on shaver blade has come loose and is half torn and folded over during surgery.Reporter stated that he was at the surgery and was the first to notice.According to the reporter, it could not be seen that the surgeon had caused it with a sharp instrument.The device was replaced and the intended procedure was completed using a similar device.There was no patient harm, no user injury reported due to the event.The subject device was disposed of by the customer.
Additional Manufacturer Narrative
The subject device was not returned for evaluation as the customer disposed the device however, photos of the damaged device was provided.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see the updates in sections h6 and h10.The device was not returned; therefore, the reported phenomenon or condition of the device could not be confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It was confirmed that the device was shipped according to the specifications.It has been over 1 year since the subject device was manufactured.The specific root cause of the reported problem could not be determined at this time because the device was not returned.The following information is stated in the instructions for use (ifu): ¿do not clean the device with a scratch pad, doing so may damage the protective insulation.".Olympus will continue to monitor field performance for this device.

• Brand Name: BIPOLAR, 4MM 40DEG, STANDARD, SERRATED, DS, 5/PK
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): GYRUS ACMI, INC; 2925 appling rd; bartlett TN 38133
• Manufacturer Contact: todd brill ; 2925 appling rd; bartlett, TN 38133 ; 5082077661
• MDR Report Key: 15443471
• Report Number: 1037007-2022-00018
• Device Sequence Number: 4729679
• Product Code: GEI
• UDI-Device Identifier: 00821925028043
• UDI-Public: 00821925028043
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K123429
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2022

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: BB4040SS
• Device Lot Number: AV106061
• Was Device Available for Evaluation?: No
• 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: 08/21/2022
• Supplement Date Received by Manufacturer: 09/19/2022
• Initial Report FDA Received Date: 09/18/2022
• Supplement Report FDA Received Date: 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown