MAUDE Adverse Event Report: KARL STORZ SE & CO. KG OBTURATOR, FOR 27026B/BB, 27027B/BB

Model Number	27026BO
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to the factory for evaluation.As per their evaluation: upon evaluation it could be confirmed that the tip was loosened.The tip was returned; therefore, it is suspected that the tip was not left in patient.Remains of the adhesive are visible on the shaft and in the thread.The device was manufactured in january 2010.Lt is suspected that the device was in use for almost 10 years.The root cause most likely is end of device life due to wear and tear.No indication for a material or manufacturing related issue.
Event or Problem Description
As per a report received by the factory in (b)(6), the tip of the obturator broke inside the patient and fell into the bladder.Tip was retrieved, and there was no harm to the patient.

• Brand Name: OBTURATOR, FOR 27026B/BB, 27027B/BB
• Common Device Name: OBTURATOR
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 9958926
• Report Number: 9610617-2020-00039
• Device Sequence Number: 2596164
• Product Code: ODB
• UDI-Device Identifier: 04048551074138
• UDI-Public: 4048551074138
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K943697
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/17/2020

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: 27026BO
• Device Catalogue Number: 27026BO
• Device Lot Number: NZ
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 04/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other