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

Model Number 27290M

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/01/2019

Event Type  malfunction  

Manufacturer Narrative

No indication for a material or manufacturing related issue was found during the investigation.The root cause most likely is a combination of corrosion due to insufficient cleaning and high force application, which led to overloading of the instrument and breakage.

Event Description

Per the factory in (b)(6), allegedly, there was an event occurred in (b)(6) during a procedure, a piece broke off and fell inside the patient; it is unclear if the broken piece remained in the patient.

• Brand Name: FORCEPS, GRASPING
• Type of Device: FORCEPS GRASPING LARGE STONE
• 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 ; 4242188201
• MDR Report Key: 9570073
• MDR Text Key: 193426483
• Report Number: 9610617-2020-00003
• Device Sequence Number: 1
• Product Code: FGA
• UDI-Device Identifier: 04048551082508
• UDI-Public: 4048551082508
• Combination Product (y/n): N
• Reporter Country Code: PM
• PMA/PMN Number: K940594
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27290M
• Device Catalogue Number: 27290M
• Device Lot Number: SR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 68