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

Model Number	C4120
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned for evaluation but lot # is provided.A device history report is to be reviewed by engineering.A final report will be sent once the results have been analyzed.This report is a follow-up to medwatch #5083609.
Event or Problem Description
Procedure performed: esophagostomy.Limited information available at this time.The blue atraumatic pads are falling off of the jaws.The pads were retrieved out of the patient.The entire pad detached from the jaws.Did not know how the grasper was being used at the time of the incident.Did not know how the procedure was completed.Product was discarded.Additional information received via email on (b)(6) 2019 from account manager: the case was on (b)(6) 2019.It was an esophagostomy by [doctor].It was used to grasp and the blue pads came off the grasper and one of them could not be found.They did have to use another grasper.Additional information mw5083609 was received via mail on (b)(6) 2019 from the fda: mw5083609.Event date: (b)(6) 2019.C4120 lot number 1340949.Device not available for return.Event description: during a robotic esophagectomy with gastric pull-up case, an applied medical grasper malfunctioned.The two blue fabric pads on the instrument came off into the patient's abdomen.One pad was easily found.The other was either flushed out or remains (non-radiopaque and not visible on x-ray taken).Patient status: fine.Type of intervention: they did have to use another grasper.
Event or Problem Description
Procedure performed: esophagostomy.Limited information available at this time.The blue atraumatic pads are falling off of the jaws.The pads were retrieved out of the patient.The entire pad detached from the jaws.Did not know how the grasper was being used at the time of the incident.Did not know how the procedure was completed.Product was discarded.Additional information received via email on (b)(6) 2019 from account manager: the case was on (b)(6) 2019.It was an esophagostomy by [doctor].It was used to grasp and the blue pads came off the grasper and one of them could not be found.They did have to use another grasper.Additional information mw5083609 was received via mail on (b)(6) 2019 from the fda: mw5083609.Event date: (b)(6) 2019.C4120 lot number 1340949.Device not available for return.Event description: during a robotic esophagectomy with gastric pull-up case, an applied medical grasper malfunctioned.The two blue fabric pads on the instrument came off into the pateint's abdomen.One pad was easily found.The other was either flushed out or remains (non-radiopaque and not visible on x-ray taken).Patient status: fine.Type of intervention: they did have to use another grasper.
Additional 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.In the absence of the event unit, it is difficult to determine the exact root cause of the event.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.

• Brand Name: C4120, 38CM LATIS GRASPER CART, 10/BX
• Common Device Name: NWV
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8380312
• Report Number: 2027111-2019-00368
• Device Sequence Number: 19555075
• Product Code: NWV
• UDI-Device Identifier: 00607915116866
• UDI-Public: (01)00607915116866(17)211113(30)01(10)1340949
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2019

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: 11/13/2021
• Device Model Number: C4120
• Device Catalogue Number: 101472471
• Device Lot Number: 1340949
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 02/28/2019
• Supplement Report FDA Received Date: 05/01/2019
• Patient Sequence Number: 1