MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C5223, REUSABLE GRASPER HANDLE; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Model Number C5223

Device Problem Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

The incident device is anticipated to return.A follow-up report will be provided upon completion of investigation.

Event Description

Procedure performed: tlh.(b)(4) 1 of 2; (b)(4) 2 of 2.The jaws of the cartridge c4120, couldn't release tissue, so tried removing handle, but think the handle might be faulty too.The tissue was ultimately released, and no harm to patient.Intervention: ni.Patient status: patient is fine, and completely unaffected.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and the complainant¿s experience could not be replicated or confirmed.Applied medical has reviewed the details surrounding the event and is unable to confirm that a product malfunction occurred.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.This event was initially reported in error based on the initial description of the event.After receiving additional information, it was determined that the event is not reportable as the jaws were removed from the tissue without injury and it is unlikely to cause or contribute to death or serious injury.This report is to follow up medwatch report # 2027111-2020-00617.

Event Description

Procedure performed: tlh the jaws of the cartridge c4120, couldn't release tissue, so tried removing handle, but think the handle might be faulty too.The tissue was ultimately released and no harm to patient.Additional information received via email from customer relations on (b)(6) 2020."i have confirmed with the rep that the hospital will not be returning the product and it has gone back into circulation at the hospital, due to there being no fault." intervention: ni.Patient status: patient is fine, and completely unaffected.

• Brand Name: C5223, REUSABLE GRASPER HANDLE
• Type of Device: LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 10830435
• MDR Text Key: 216185568
• Report Number: 2027111-2020-00617
• Device Sequence Number: 1
• Product Code: NWV
• 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: 02/09/2021

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 Model Number: C5223
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/09/2020
• Initial Date FDA Received: 11/12/2020
• Supplement Dates Manufacturer Received: 11/09/2020
• Supplement Dates FDA Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1