MAUDE Adverse Event Report: KARL STORZ SE & CO. KG GRASPER FORCEPS DOUBLE ACTION JAW 3FR X 38CM; SEMI -RIGID GRASPER

Model Number	11510C
Medical Device Problem Codes	Material Fragmentation (1261); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Per salesrep who was notified by the facility, that during a feto balloon removal, one of the teeth of the feto grasper broke off inside the fetus.A detailed search with a fetoscope could not locate the piece and it was assumed flushed out of the fetus during the procedure.A follow up is planned once the baby is born to see if tooth remains inside.
Additional Manufacturer Narrative
Product has not been returned; therefore, product has not been evaluated.
Additional Manufacturer Narrative
Product has been received by mfr.Tension rod broken causing jaws to become inoperable.Shaft is also deformed but not the cause of the tension rod being broken.The product manufactured date is may of 2019.The product is a class 1 and according to the manufacture there is no ifu.The findings were mechanical overload due to excessive force, based on the customer's complaint description.The joints of the jaw are completely deformed and are broken off based on the report of the mfr.The obvious cause, based on the customer's description and investigation, is mechanical overload due to excessive force.Due to the high force, the joint retainers were sheared off the joint pin.No corrective actions necessary as there is no critical and/or systematic deviation found during investigation the current issue did not trigger the capa as per q3.3.0001 corrective and preventive action.

• Brand Name: GRASPER FORCEPS DOUBLE ACTION JAW 3FR X 38CM
• Common Device Name: SEMI -RIGID GRASPER
• 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: 15300307
• Report Number: 9610617-2022-00252
• Device Sequence Number: 7222721
• Product Code: HET
• UDI-Device Identifier: 04048551050958
• UDI-Public: 4048551050958
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K951343
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 11510C
• Device Catalogue Number: 11510C
• Device Lot Number: SQ01
• 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: 07/29/2022
• Supplement Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 08/26/2022
• Supplement Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2019
• 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