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	Foreign Body In Patient (2687)
Date of Event	11/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufactors complaint:(b)(4).Investigation on-going.Product requested but not yet received.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.
Event or Problem Description
The grasper forceps is used to remove a balloon inside a fetal airway after the balloon is punctured.In this case the balloon was puncture (normal practice) but balloon was left in because the grasper was broken.Balloon will be removed once the fetus is delivered by ent.Potential harm to fetus as fetus will now have to have a procedure once born to remove the balloon that we were not able to remove due to the broken forceps.The broken piece did not happen inside the fetus but it did occur inside the uterus and amniotic fluid.X rays were not used to verify grasper piece as x-ray's aren't recommended in pregnancy.The grasper was processed as per canadian hospital sterilization standards.The grasper forceps was inserted inside the fetal trachea for removal of balloon, attempt was made to grasp the balloon by surgeon.The grasper was repositioned and when it was opened to try and grasp the balloon again the little piece below the teeth appeared to malfunction and would not open the teeth on the grasper.Grasper was removed from the uterus and balloon was puncture with needle and left in.On inspection after the procedure the grasper forceps still not reopen.
Additional Manufacturer Narrative
Per manufacture investigation findings, the product was produced in may 2019.The product is a class 1 with no ifu.The joints of the jaw are completely deformed and broken off which shows high force.Per the findings due to the high force, the joint retainers were sheared off the joint pin.There will be no corrective action as there was no systematic deviation found during investigation.

• 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, ; 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: 15886114
• Report Number: 9610617-2022-00305
• Device Sequence Number: 17455558
• 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): 06/29/2023

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: OY
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2022
• Supplement Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 08/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention; Other
• Patient Age: 32 YR
• Patient Sex: Female