MAUDE Adverse Event Report: KARL STORZ SE & CO. KG GRASPING FORCEPS FOR LARGE STONE; STONE GRASPING FORCEPS

Model Number 27290K

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.Damage is most likely due to stress overload.The instrument had been in use for over seven years.

Event Description

Allegedly, during a pcnl procedure, one of the jaws of the stone grasping forceps broke off inside the patient.The broken jaw was retrieved.There was no harm to patient.

• Brand Name: GRASPING FORCEPS FOR LARGE STONE
• Type of Device: STONE GRASPING 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: 8259130
• MDR Text Key: 133526133
• Report Number: 9610617-2019-00011
• Device Sequence Number: 1
• Product Code: FGA
• UDI-Device Identifier: 04048551082485
• UDI-Public: 4048551082485
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K940594
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27290K
• Device Catalogue Number: 27290K
• Device Lot Number: WZ01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2010
• 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): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 76