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

Model Number C4121

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2020

Event Type  malfunction  

Manufacturer Narrative

The event unit is anticipated to return for evaluation.A follow-up report will be provided upon completion of the investigation.

Event 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.

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 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
• Type of Device: LAPAROCOPIC ACESSORIES, GYNECOLOGIC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 10472204
• MDR Text Key: 205015359
• Report Number: 2027111-2020-00538
• Device Sequence Number: 1
• Product Code: NWV
• UDI-Device Identifier: 00607915116873
• UDI-Public: (01)00607915116873(17)230119(30)01(10)1379932
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 08/12/2020
• Initial Date FDA Received: 08/31/2020
• Supplement Dates Manufacturer Received: 08/12/2020
• Supplement Dates FDA Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1