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

Model Number 27026BO

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 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
• Type of Device: OBTURATOR
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, ca ; 2188201
• MDR Report Key: 9958926
• MDR Text Key: 198354472
• Report Number: 9610617-2020-00039
• Device Sequence Number: 1
• Product Code: ODB
• UDI-Device Identifier: 04048551074138
• UDI-Public: 4048551074138
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K943697
• 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: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27026BO
• Device Catalogue Number: 27026BO
• Device Lot Number: NZ
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/06/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2010
• 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
• Patient Outcome(s): Other