MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C4121, 45CM LATIS GRASPER CART, 10/BX; LAPAROCOPIC ACESSORIES, GYNECOLOGIC

Model Number	C4121
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Name of procedure performed: unknown.Detailed description of event: material pad inside the grasper started to fray.Another product was opened.Additional information received via email from [name] on 26aug2020: received 3 pictures of unit device patient status: patient is fine and completely unaffected.Type of intervention: product was replaced with another.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed that the latis of the grasper pad was frayed.The latis weld was inspected and there were no signs of a manufacturing defect.Based on the condition of the returned unit, the reported event was caused by a broken latis weld, which occurred while the device was being used.Applied medical is unable to determine the root cause of the broken latis weld based on the evaluation of the returned unit.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: unk material pad inside the grasper started to fray.Another product was opened.Additional information received via email from customer relations, [name] on 26aug2020: received 3 pictures of unit device.Intervention: product was replaced with another.Patient information: patient is fine, and completely unaffected.

• Brand Name: C4121, 45CM LATIS GRASPER CART, 10/BX
• Common Device Name: LAPAROCOPIC ACESSORIES, GYNECOLOGIC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 10472204
• Report Number: 2027111-2020-00538
• Device Sequence Number: 11349009
• Product Code: NWV
• UDI-Device Identifier: 00607915116873
• UDI-Public: (01)00607915116873(17)230119(30)01(10)1379932
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2020

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 Expiration Date: 01/19/2023
• Device Model Number: C4121
• Device Catalogue Number: 101473344
• Device Lot Number: 1379932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/12/2020
• Supplement Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 11/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1