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

Model Number	C4120
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device is anticipated to return.A follow-up report will be provided upon completion of investigation.
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 10830324
• Report Number: 2027111-2020-00616
• Device Sequence Number: 14363558
• Product Code: NWV
• UDI-Device Identifier: 00607915116866
• UDI-Public: (01)00607915116866(17)230521(30)01(10)1386285
• 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): 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
• Operator of Device: 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 Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 01/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1