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

Model Number	G27L-12A
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Dent in Material (2526)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to olympus with the user reported issue of "cracked interior lens." the event was found at reprocessing, and there was no patient or other person affected/ involved in the event.Upon inspection of the received device, the complaint of fractured lenses was not confirmed.However, sharp dents on distal end were observed.Severe debris under cover glass and in the optical system was also noted.Based on inspection results, the damage which occurred was most likely due to user mishandling along with excessive force being applied to the distal outer tube.Device history records were reviewed and showed the product met all specifications upon release.The device ifu (instructions for use) 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.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
As reported, the device has a cracked interior lens.This was found during reprocessing.Device return found sharp dents on distal end.There is no patient involvement on this reported event.No user injury reported.

• 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
• Manufacturer Contact: kenneth pittman ; 93 north pleasant st.; norwalk, OH 44857 ; 9013785969
• MDR Report Key: 13014032
• Report Number: 1519132-2021-00024
• Device Sequence Number: 1816617
• Product Code: FAS
• UDI-Device Identifier: 00821925008410
• UDI-Public: 00821925008410
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/15/2021

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: 10/25/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown