MAUDE Adverse Event Report: GYRUS ACMI, INC CYSTOURETHROSCOPE STANDARD OBTURATOR, 17FR

Model Number	E117-O
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported with an issue of broken end bottom of obturator.The issue found during reprocessing.There is no patient involvement associated on this reported event.No user injury reported.
Additional Manufacturer Narrative
The subject device e117-o with lot ku was returned to olympus with the user request of "broken end bottom of obturator.Device evaluation and inspection, the customer reported issue was confirmed.The distal end was broken, the broken fragment was also sent in with the unit.No additional defects were noted.Based on the device inspection findings and the incident information provided , the damage which occurred was most likely due to user mishandling during device reprocessing.This unit was produced in november 2015.Device history records were reviewed and showed the product met all specifications upon release.The provided dhrs do not include packaging or labeling operations.For this reason, a final manufacture date is not available.The device ifu (instructions for use), rev 99-1034_dj, 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" (page 4).Olympus will continue to monitor complaints for this device.

• Brand Name: CYSTOURETHROSCOPE STANDARD OBTURATOR, 17FR
• Common Device Name: CYSTOURETHROSCOPE STANDARD OBTURATOR
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: brian motter ; 93 north pleasant st.; norwalk, OH 44857 ; 4848965250
• MDR Report Key: 13974210
• Report Number: 1519132-2022-00003
• Device Sequence Number: 12002170
• Product Code: FEC
• UDI-Device Identifier: 00821925002296
• UDI-Public: 00821925002296
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/01/2022

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: E117-O
• Device Lot Number: KU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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