MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C4121, 45CM GRASPER REPOS CART, 10/BX; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Model Number C4121

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/25/2020

Event Type  malfunction  

Manufacturer Narrative

Ra has just received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.

Event Description

Procedure performed: robotic oesophagectomy mr [name] was performing the surgery.Mid procedure, the grasper tips became loose and flimsy.He was unable to continue using.Additional information received via email from [name] (rep) on 02.06.2020: "the grasper tips became loose and flimsy" are you referring to the pads or the actual jaw itself? the jaws were faulty.Can you please provide a picture of the event unit? the hospital is unable to provide a photograph.Intervention: ni.Patient status: patient is fine, and completely unaffected.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual inspection determined that the latis portion of the pad was frayed, which confirmed the complainant¿s observation that the tips of the grasper became loose and flimsy.Based on the condition of the returned unit and description of the event, it is likely the frayed latis pad was not caused by a manufacturing defect.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: robotic osophaegectomy mr [name] was performing the surgery.Mid procedure, the grasper tips became loose and flimsy.He was unable to continue using.Additional information received via email from [name] (rep) on (b)(6) 2020: "the grasper tips became loose and flimsy" are you referring to the pads or the actual jaw itself? the jaws were faulty.Can you please provide a picture of the event unit? the hospital is unable to provide a photograph.Patient status: patient is fine, and completely unaffected.

• Brand Name: C4121, 45CM GRASPER REPOS 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: 10399255
• MDR Text Key: 203133981
• Report Number: 2027111-2020-00526
• 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: 08/26/2020

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 Model Number: C4121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/21/2020
• Initial Date FDA Received: 08/12/2020
• Supplement Dates Manufacturer Received: 07/21/2020
• Supplement Dates FDA Received: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1