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

Model Number C4121

Device Problem Separation Failure (2547)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2021

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: robot assist paraesophageal hernia repair w/mesh.Limited information is available at this time.The rep was called by the facility contact and informed that the product was not working correctly.A new device was used to complete the case.The procedure is unknown.The tissue the device was used on is unknown.Product is available for return.Additional information received via email on 29mar2021 from [name], applied medical account manager i.There was no patient injury.During intra-abdominal procedure" the reposable grasper screw loosened.After removal from the port, the grasper fell apart into 3 pieces.No photos are available.Additional information received via email on 29mar2021 from [name], applied medical account manager i.This happen at the beginning of the case.Ended up using another grasper and it worked just fine.12mm trocar was the size and nothing fell into the patient.Intervention: used another product to complete the case.Patient status: there was no patient injury.

Manufacturer Narrative

Updating alert date from 26mar21 to correct alert date 29mar21 for reportability.

Event Description

Procedure performed: robot assist paraesophageal hernia repair w/mesh.Limited information is available at this time.The rep was called by the facility contact and informed that the product was not working correctly.A new device was used to complete the case.The procedure is unknown.The tissue the device was used on is unknown.Product is available for return.Additional information received via email on 29mar2021 from [name], applied medical account manager i.There was no patient injury.During intra-abdominal procedure" the reposable grasper screw loosened.After removal from the port, the grasper fell apart into 3 pieces.No photos are available.Additional information received via email on 29mar2021 from [name], applied medical account manager i.This happen at the beginning of the case.Ended up using another grasper and it worked just fine.12mm trocar was the size and nothing fell into the patient.Intervention: used another product to complete the case patient status: there was no patient injury.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.The rivet of the returned unit was dislodged, which caused the jaws to disconnect from the shaft.The swaged end of the rivet was malformed.Applied medical has reviewed the details surrounding the event and related product and is unable to determine the exact root cause of the reported event based on the evaluation of the event unit.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: robot assist paraesophageal hernia repair w/mesh event description: limited information is available at this time.The rep was called by the facility contact and informed that the product was not working correctly.A new device was used to complete the case.The procedure is unknown.The tissue the device was used on is unknown.Product is available for return.Additional information received via email on 29mar2021 from [name], applied medical account manager i: there was no patient injury.During intra-abdominal procedure" the reposable grasper screw loosened.After removal from the port, the grasper fell apart into 3 pieces.No photos are available.Additional information received via email on 29mar2021 from [name], applied medical account manager i: this happen at the beginning of the case.Ended up using another grasper and it worked just fine.12mm trocar was the size and nothing fell into the patient.Intervention: used another product to complete the case.Patient status: there was no patient injury.

• Brand Name: C4121, 45CM GRASPER REPOS CART, 10/BX
• Type of Device: LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 11758236
• MDR Text Key: 249671556
• Report Number: 2027111-2021-00474
• Device Sequence Number: 1
• Product Code: NWV
• UDI-Device Identifier: 00607915116873
• UDI-Public: (01)00607915116873(17)231120(30)01(10)1401962
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/29/2021

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: 11/20/2023
• Device Model Number: C4121
• Device Catalogue Number: 101472473
• Device Lot Number: 1401962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/29/2021
• Initial Date FDA Received: 04/30/2021
• Supplement Dates Manufacturer Received: 03/29/2021; 03/29/2021
• Supplement Dates FDA Received: 04/30/2021; 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1