MAUDE Adverse Event Report: KARL STORZ SE & CO. KG OPTICAL STONE CRUSHING FORCEPS

Model Number 27074B

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2019

Event Type  malfunction  

Manufacturer Narrative

The subject device has not yet been returned for evaluation.A supplemental report will be filed if/when device is returned.

Event Description

Allegedly, during a cystolithotripsy and cystolitholapaxy procedure, a piece, or pieces, of the forceps broke off into the patient.They retrieved the piece(s) and procedure was completed with no harm to patient.

• Brand Name: OPTICAL STONE CRUSHING FORCEPS
• Type of Device: STONE CRUSHING FORCEPS
• 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 90245-5017 ; 4242188201
• MDR Report Key: 9593884
• MDR Text Key: 188081338
• Report Number: 9610617-2019-00121
• Device Sequence Number: 1
• Product Code: OCZ
• UDI-Device Identifier: 04048551079386
• UDI-Public: 4048551079386
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K950434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 27074B
• Device Catalogue Number: 27074B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 64 YR
• Patient Weight: 59