MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES DIRECT DRIVE REPOSABLE GRASPERS; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Model Number	C4120
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	07/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: ni.Event description: grasper was working fine when taken out of package.Product broke inside patient during operation.Hss has received a product complaint from [hospital], see product detail below: product: direct drive reposable graspers supplier part number: n/a.Batch: 1545993.Supplier: applied medical.Complaint: ["damaged/requires repair or replacement".Description: grasper was working fine when taken out of packaging.Product broke inside patient during the operation.Action: product was assessed to see if any parts were possibly within the patient cavity.A new grasper was opened.Is product available? yes.Is packaging available? yes.Can you please liaise directly with the complainant to arrange pick up of the faulty item/s.We request that a written corrective action plan is provided, clearly defining a planned solution and a timeframe by the kpi deadline of 21 august 2025.No clinical impact.Additional info received by amr rep via email on august 18, 2025: 1.What component of the device broke? hinge broke and came loose on the neck of grasper.2.What circumstances that led to the break? the circumstances leading to the incident was that the grasper was working fine and after inserting it back into the patient, the surgeon noticed it wasn't functioning.3.What is the size/composition of detached fragments (if any)? one side of the hinge was still attached to the grasper.I'd say its about 1cm long in total.Additional info received by amr rep via email on august 20, 2025: reply from [complainant]: the hinge was still attached on one end to the grasper; it was just hanging from the grasper.The whole piece did not come off and the surgeons did have a look inside the patient.Estimate the hinge is about 1cm long in total.Intervention: product was assessed to see if any parts were possibly within the patient cavity.Patient status: unknown.
Additional Manufacturer Narrative
The event device is anticipated to return.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: ni.Event description: grasper was working fine when taken out of package.Product broke inside patient during operation.Hss has received a product complaint from [hospital], see product detail below: product: direct drive reposable graspers.Supplier part number: n/a.Batch: 1545993.Supplier: (b)(4).Complaint: ["damaged/requires repair or replacement"] description: grasper was working fine when taken out of packaging.Product broke inside patient during the operation.Action: product was assessed to see if any parts were possibly within the patient cavity.A new grasper was opened.Is product available? yes.Is packaging available? yes.Can you please liaise directly with the complainant to arrange pick up of the faulty item/s.We request that a written corrective action plan is provided, clearly defining a planned solution and a timeframe by the kpi deadline of 21 august 2025.No clinical impact.Additional info received by amr rep via email on august 18, 2025: 1.What component of the device broke? hinge broke and came loose on the neck of grasper.2.What circumstances that led to the break? the circumstances leading to the incident was that the grasper was working fine and after inserting it back into the patient, the surgeon noticed it wasn't functioning.3.What is the size/composition of detached fragments (if any)? one side of the hinge was still attached to the grasper.I'd say its about 1cm long in total.Additional info received by amr rep via email on august 20, 2025: reply from [complainant]: the hinge was still attached on one end to the grasper; it was just hanging from the grasper.The whole piece did not come off and the surgeons did have a look inside the patient.Estimate the hinge is about 1cm long in total.Intervention: product was assessed to see if any parts were possibly within the patient cavity.Patient status: no clinical impact.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed that the jaws were dislodged from the slot track and one side of the jaw had fractured.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event based on the evaluation of the returned unit.Applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.This event was initially reported based on the description of the event.However, based on the evaluation of the returned unit, applied medical determined that this event is not reportable as it is unlikely to cause or contribute to death or serious injury.

• Brand Name: DIRECT DRIVE REPOSABLE GRASPERS
• Common Device Name: LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135359
• MDR Report Key: 22868967
• Report Number: 2027111-2025-00706
• Device Sequence Number: 9123150
• Product Code: NWV
• UDI-Device Identifier: 00607915116866
• UDI-Public: (01)00607915116866
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

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: C4120
• Device Catalogue Number: 101476259
• Device Lot Number: 1545993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown