MAUDE Adverse Event Report: GYRUS ACMI, INC GYN OPERATIVE 12 DEGREE 2.7MM LONG AUTOCLAVABLE; PNEUMOPERITONEUM NEEDLE

Model Number	REXG27L-12A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device has been returned to olympus for evaluation and the investigation is in process.Upon initial inspection, the olympus service center confirmed the outer tube was bent and the internal lenses were cracked, causing a loss of image.Debris under eyepiece window was also observed.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem Description
It was reported to olympus, the device shaft was bent and there wasn't an image.The malfunction was identified in reprocessing on (b)(6) 2021.No patient involvement.
Additional Manufacturer Narrative
This supplement is being submitted to correct the model number and udi number per legal manufacturer review of device history report.
Additional Manufacturer Narrative
This supplemental report is submitted to provide the results of the legal manufacturer¿s investigation and the results of the device history records (dhr) review.The dhr for this device were reviewed and all records indicated the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.A definitive root cause was not determined.However, based on the inspection result, physical damage found on the device was most likely due to user mishandling.The device instructions for use provides warnings and cautions to alert that the device may be damaged by improper handling.It states "study this manual and other labeling thoroughly for safe handling and storage.Misuse of instruments can cause injury to the patient and could have an adverse effect on the procedure being performed.Do not drop instruments or allow them to be struck by other objects.".

• Brand Name: GYN OPERATIVE 12 DEGREE 2.7MM LONG AUTOCLAVABLE
• Common Device Name: PNEUMOPERITONEUM NEEDLE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11962019
• Report Number: 3011050570-2021-00076
• Device Sequence Number: 11803875
• Product Code: FHO
• UDI-Device Identifier: 00821925008915
• UDI-Public: 00821925008915
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K980972
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/29/2021

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: REXG27L-12A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 06/16/2021; 06/16/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 06/22/2021; 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1