MAUDE Adverse Event Report: KARL STORZ SE & CO. KG STONE EXTRACTOR, 0.6 MM, 4 WIRES; SALIVARY STONE RETRIEVAL BASKET

Model Number	11573T
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Current location of device is unknown.Device not received so far; therefore, no investigation possible as of yet.
Event or Problem Description
As per a manufacturer incident report we received from the factory in (b)(6): as reported: "during dilation of parotid strictures straight by sialoendoscopy, the distal end in plastic tip of the basket probe has torn about 4mm and got stuck in the sténon canal.Patient suffers from pain and was prescribed corticosteroids.This incident was declared to the ansm.".

• Brand Name: STONE EXTRACTOR, 0.6 MM, 4 WIRES
• Common Device Name: SALIVARY STONE RETRIEVAL BASKET
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 12185470
• Report Number: 9610617-2021-00055
• Device Sequence Number: 1533195
• Product Code: GCJ
• UDI-Device Identifier: 04048551276921
• UDI-Public: 4048551276921
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K012527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 11573T
• Device Catalogue Number: 11573T
• Device Lot Number: 10157010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 07/16/2021
• 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