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

Model Number	G27L-12A
Medical Device Problem Codes	Break (1069); Defective Device (2588)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was evaluated.Inspection of the device confirmed the reported issue.Device was found with fractured internal lens.Investigation is ongoing therefore the root cause cannot be determined at this time.If additional information becomes available this report will be supplemented accordingly.
Event or Problem Description
It was reported that the device was found with fractured internal lens.The issue occurred during reprocessing.There was no patient involvement on this event reported.No user injury reported.
Additional Manufacturer Narrative
This supplemental report is to inform that upon further review, this is not a reportable malfunction.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.

• Brand Name: GYN OPERATIVE 12 DEGREE 2.7MM LONG AUTOCLAVABLE
• Common Device Name: GYN OPERATIVE 12 DEGREE 2.7MM LONG AUTOCLAVABLE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11261542
• Report Number: 1519132-2021-00003
• Device Sequence Number: 728527
• Product Code: FHO
• UDI-Device Identifier: 00821925008915
• UDI-Public: 00821925008915
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K980972
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2021

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: G27L-12A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 02/01/2021
• Supplement Report FDA Received Date: 02/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1