MAUDE Adverse Event Report: GYRUS ACMI, INC. UROPASS AS 13/15FR X 38 CM 5/BX; URETERAL CATHETER

Model Number	61338BX
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus received a medwatch report (uf# (b)(4)) through the mail which stated: "facilities have identified an issue with the disposable olympia uropass access sheath tips- it is breaking apart within the package and during the procedure.Multiple lot# and product # are affected.Multiple tips across various procedures broke off of the device during the procedures.The surgeons were able to recover them without any harm to the patient.Our clinicians have also noted that the tip of the device can be easily broken off within the package.Multiple lot numbers/product numbers affected".Upon further inquiry, it was reported the tips broke off within patients during procedure.Imaging was conducted and the surgery was delayed to invasively remove the tips from patient(s).No patient harm was reported and no patient information has been provided.The following medwatch reports are related.The patient identifiers are as follows: (b)(6), model #: 61224bx, lot #: 09e2100062; (b)(6), model #: 61134bx, lot #: 09j1800111; (b)(6), model #: 61238bx, lot #: 09b1900153; (b)(6), model #: 61338bx, lot #: 09a1900139; (b)(6), model #: 61324bx, lot #: 09d2000303; (b)(6), model #: 61138bx, lot #: 09l2100130.This medwatch report is for patient identifier (b)(6).
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and evaluation with correction to the initial with information inadvertently left out.Additionally, to provide a correction to the initial (b5) and to provide updates to the initial (d9 and h3).A recall (recall # 0426) of devices unexpired devices manufactured prior to 31dec2019.Recall number is unavailable at the time of this report.The reported complaint was confirmed through evaluation and investigation of the device, therefore, there is no concomitant device for this complaint due to the device not being used and the customer returning this product out of caution.There were 4 devices returned from this specific lot 09a1900139.Of the 4 devices returned, there was one confirmed breakage.The tip of the device was broken inside the unopened package.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is possible the suggested event occurred due to the following: 1.Uropass dilator tip breakage is proposed to be mainly caused by inconsistent manufacture process of polyethylene (pe) dilator, lot-by-lot.2.The unfavorable oxidation of polyethylene dilator material is proposed to be occurred during dilator manufacture thermal process cycle, in which the thermos-oxidation could cause brittle fracture of uropass dilator tip materials for special lots.3.Generally speaking, photooxidation of polyethylene or uropass dilator material could occur during the whole products cycle including sterilization, and shelf life.In other words, it will have affecting on uropass products for every lots but not for special lots.4.Uropass dilator tip buckling testing should be very helpful for supplier to check the quality of uropass dilator tip for each lot to make sure if it meets osta specifications or not.However, the root cause of the device malfunction could not be determined.Olympus will continue to monitor field performance for this device.
Event or Problem Description
C22475559 model# 61154bx / lot # 09j1800111.

• Brand Name: UROPASS AS 13/15FR X 38 CM 5/BX
• Common Device Name: URETERAL CATHETER
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer (Section G): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16061958
• Report Number: 3003790304-2022-00363
• Device Sequence Number: 6686539
• Product Code: KNY
• UDI-Device Identifier: 00821925035447
• UDI-Public: 00821925035447
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K051593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 61338BX
• Device Lot Number: 09A1900139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/29/2022
• Supplement Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 12/28/2022
• Supplement Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: TBD (PLEASE SEE H10)
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown