MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY KARL STORZ ENDOSCOPY; STONE EXTRACTOR, 0.4MM, 4 WIRES

Model Number	11582M
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Codes	Discomfort (2330); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	02/02/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
During the sialoendoscopy procedure multiple storz stone extractor baskets were used to attempt to extract a stone that was lodged in a salivary gland duct.The baskets (ref #s 11575l, 11575k, 11582m) were all broken at some point during the procedure whether they were opened around the stone or just from simply being opened and closed according to the physician who was performing the procedure.During one of the attempts to extract a stone basket which was opened around the stone broke off from the rest of the device and was left around the stone and lodged in place making it irretrievable.Many attempts were made to retrieve the stone and the basket around the stone, but were unsuccessful.Some of the baskets were left retained inside the salivary gland duct.Overall, 8 baskets were broken in some fashion during the course of this procedure.There were 8 stone extractor baskets used and all 8 failed.

• Brand Name: KARL STORZ ENDOSCOPY
• Common Device Name: STONE EXTRACTOR, 0.4MM, 4 WIRES
• Manufacturer (Section D): KARL STORZ ENDOSCOPY; tuttingen ; GM
• MDR Report Key: 6361350
• Report Number: 6361350
• Device Sequence Number: 16488324
• Product Code: GCJ
• UDI-Device Identifier: 04048551051863
• UDI-Public: (01)04048551051863(240)
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/10/2017
• Report Date (Section F): 02/10/2017

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 Expiration Date: 05/31/2019
• Device Model Number: 11582M
• Device Catalogue Number: 11582M
• Device Lot Number: 4144020
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/02/2017
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/15/2017
• 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: Required Intervention
• Patient Age: 59 YR
• Patient Weight: 112
• Date Report Sent to FDA: 02/14/2017