MAUDE Adverse Event Report: KARL STORZ SE & CO. KG MACRO NEEDLE HOLDER; NEEDLE HOLDER, REUSABLE

Model Number	26173KPF
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product is currently in transit to the manufacturing site.
Event or Problem Description
As per a manufacturer incident report we received from the factory in (b)(6): the patient underwent a pelviscopy during which the instrument was used.After completion of the operation, it was discovered that a hard metal insert of the needle holder was missing.The patient then underwent an x-ray examination, whereupon a fragment could be located.Another laparoscopic surgery was performed to retrieve the fragment.However, due to the unfavorable position of the fragment in the abdominal cavity, it could not be recovered and remained in the patient's body.(mfr's.Internal complaint (b)(4).).
Additional Manufacturer Narrative
The affected (b)(6) macro needle holder was received and investigated.Upon investigation of the instrument, it could be confirmed that the hard metal plate of the movable jaw-part is missing; it has come off from this part.In addition, there are deformations visible on the edge of the jaw-parts.Visual inspection also indicates that sufficient flux/solder was used in the production when the hard metal plate was fixed to the movable jaw-part, because the contact area on the jaw-part shows a coating of filler on the entire surface.Based on these observations (deformations, sufficient flux/solder), it can be assumed that the most probable root cause for the hard metal plate to come off was a mechanical overload by too much force application on the jaw.
Event or Problem Description
Further description from the user report received on 06.April 2022: "on (b)(6) 2022 colporrhaphia anterior, laparoscopy and colposacropexy with y-mesh by dr.(b)(6).Immediately postop, ota k.L.Noticed the missing hard metal on the movable retractor of the needle holder.In the x-ray abdomen of (b)(6) 2022 a metallic correlate was visible intra-abdominally.On (b)(6) 2022 re-laparoscopy with closure of a trocar hernia on the left side by dr.(b)(6) and frustrated search for branch platelets by ca dr.(b)(6) in the intra-op.X-ray (c-arm) the platelet is always visualised; however, it cannot be removed, it lies a.E.Peritoneally, close to the spinal column; postop.Monitoring in intensive care with hb drop.The patient has been informed of the facts and would like to wait and see how things progress.

• Brand Name: MACRO NEEDLE HOLDER
• Common Device Name: NEEDLE HOLDER, REUSABLE
• 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: anja fair ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 14021728
• Report Number: 9610617-2022-00030
• Device Sequence Number: 20344945
• Product Code: GCJ
• UDI-Device Identifier: 04048551098219
• UDI-Public: 4048551098219
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K951625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2022

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: 26173KPF
• Device Catalogue Number: 26173KPF
• Device Lot Number: TQ03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2022
• Supplement Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2019
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Female