MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CLICKLINE INSERT, DEBAKEY GRASPER; GRASPER INSERT ATRAUMATIC

Model Number	33310DY
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product has not been returned; therefore, product has not been evaluated.
Event or Problem Description
Per salesrep who was notified by the facility, that during a procedure the doctor was removing a sponge using a grasper.The doctor questioned the rep regarding the jaw of the grasper if a pin was part of the design.No further information has been provided by the facility if a pin from the jaw was missing.

• Brand Name: CLICKLINE INSERT, DEBAKEY GRASPER
• Common Device Name: GRASPER INSERT ATRAUMATIC
• 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, ; GM
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188100
• MDR Report Key: 15250716
• Report Number: 9610617-2022-00245
• Device Sequence Number: 12415308
• Product Code: GCJ
• UDI-Device Identifier: 04048551134207
• UDI-Public: 4048551134207
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K935071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/19/2022

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 Model Number: 33310DY
• Device Catalogue Number: 33310DY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown