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

Model Number G27L-12A

Device Problems Device Damaged Prior to Use (2284); Dent in Material (2526)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 286583394
• Report Number: 1519132-2021-00024
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 00821925008410
• UDI-Public: 00821925008410
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 11/22/2021
• Initial Date FDA Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1