MAUDE Adverse Event Report: GYRUS ACMI, INC. BIPOLAR BLADE, 2MM, STRAIGHT, STANDARD, TYPE A, SMR, 5/PK; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	BB2000SA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	12/26/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus was informed by the plaintiff's law firm, there was a complication reported during a procedure involving the subject device.The complication was reported as inadvertent entry into the orbit at the lateral aspect of the frontal recess on the left.The procedures performed during the surgery were, bilateral endoscopic: frontal sinusotomy with exploration, total ethmoidectomy, maxillary antrostomy with removal of tissue, sphenoidotomy with removal of tissue; nasal septoplasty, bilateral submucosal resection of inferior turbinates and use of non-olympus stereotactic ct navigation.The complications of the procedure were: inadvertent entry into the orbit at the lateral aspect of the frontal recess on the left.Preoperative imaging showed preoperative defect in the lamina papyracea at this site consistent with prior orbital trauma.A small piece of orbital fat was protruding through this defect.No evidence of orbital hematoma was identified throughout the entire case.The small defect was left open.No cautery was used or further trauma to the orbit after identification.Estimated blood loss: 100 ml.The surgery findings included: copious purulence within the left maxillary sinus consistent with an odontogenic sinus infection, bilateral middle meatus polyps and small polypoid tissue throughout all the sinuses, mesenteric anterior ethmoid arteries which were kept intact and not violated bilaterally, and entry into the anterior orbit noted during the dissection of the lateral frontal recess with small piece of fat noted to be protruding into the left anterior ethmoid cavity.
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The device was not returned, therefore a physical evaluation to confirm or not confirm the reported failure was not performed.If the device is returned, the complaint will be reopened and updated with information.Based on the results of the investigation by the original equipment manufacturer (oem), there is no manufacturing, material or processing related cause for this failure mode of an olympus manufactured device.The root cause has been determined to be the usage of another company's device.Olympus will continue to monitor field performance for this device.

• Brand Name: BIPOLAR BLADE, 2MM, STRAIGHT, STANDARD, TYPE A, SMR, 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: 15739773
• Report Number: 1037007-2022-00021
• Device Sequence Number: 6203270
• Product Code: GEI
• UDI-Device Identifier: 00821925038127
• UDI-Public: 00821925038127
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2022

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: BB2000SA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2022
• Supplement Date Received by Manufacturer: 11/11/2022
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NON-OLYMPUS CT NAVIGATION SYSTEM
• Outcome Attributed to Adverse Event: Other
• Patient Age: 38 YR
• Patient Sex: Male