MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY KARL STORZ ENDOSCOPY; STONE EXTRACTOR, 0.6MM

Model Number 11575L

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Material Separation (1562)

Patient Problems Discomfort (2330); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 02/02/2017

Event Type  Injury  

Event 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
• Type of Device: STONE EXTRACTOR, 0.6MM
• Manufacturer (Section D): KARL STORZ ENDOSCOPY; tuttingen ; GM
• MDR Report Key: 6361356
• MDR Text Key: 68540640
• Report Number: 6361356
• Device Sequence Number: 1
• Product Code: FGO
• UDI-Device Identifier: 04048551051689
• UDI-Public: (01)04048551051689(240)
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: 11575L
• Device Catalogue Number: 11575L
• Device Lot Number: 6532010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/14/2017
• Distributor Facility Aware Date: 02/02/2017
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 112