MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C4120, 38CM LATIS GRASPER CART, 10/BX; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Model Number C4120

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

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.Cer2020-002610 1 of 2; cer2020-002611 2 of 2.Grasper would not release tissue after holding tissue between jaws.The clinicians tried to open the grasper by removing the handle, and the jaws still didn't open.This was attempted 3 times with, and without the handle, and eventually the tissue was released with no injury to patient.Intervention: ni.Patient status: patient is fine, and completely unaffected.

Event Description

Procedure performed: tlh grasper would not release tissue after holding tissue between jaws the clinicians tried to open the grasper by removing the handle and the jaws still didn't open.This was attempted 3 times with and without the handle and eventually the tissue was released with no injury to patient.Patient status: patient is fine, and completely unaffected.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Engineering disassembled the event unit and observed that one of the jaws had dislodged from its track.Damage was also observed on the post of the jaw.Based on the condition of the returned unit and the description of the event, the jaws were unable to open due to the dislodgement of one of the jaws.It is likely that this was caused by a large force that was applied to the jaws during use, which damaged the post of the jaw.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 and 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 # 2027111-2020-00616.

• Brand Name: C4120, 38CM LATIS GRASPER CART, 10/BX
• Type of Device: LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 10830324
• MDR Text Key: 216624485
• Report Number: 2027111-2020-00616
• Device Sequence Number: 1
• Product Code: NWV
• UDI-Device Identifier: 00607915116866
• UDI-Public: (01)00607915116866(17)230521(30)01(10)1386285
• 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: 01/28/2021

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 Expiration Date: 05/21/2023
• Device Model Number: C4120
• Device Catalogue Number: 101473343
• Device Lot Number: 1386285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• 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: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1