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

Model Number C4120

Device Problems Material Frayed (1262); Detachment of Device or Device Component (2907)

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

Event Date 02/11/2021

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: lower anterior colon resection.The account mgr was present for the case.[name] was performing a lower anterior colon resection.The grasper was being used with the ctf03 trocar.He noticed that the jaws of the grasper were misaligned.He was not grabbing tissue at the time and had already placed the drain in the patient.He stated that he did not recollect when or how the jaw became misaligned.A new grasper was opened and the case was completed.There was no damage to the tissue.There was no patient injury.There are no photos available.The device is available to be returned.Replaced with a new grasper.No patient injury.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual inspection confirmed that the grasper jaws were misaligned.One of the pads had partially detached from the grasper jaw.The adhesive remnants and pad fragments on the jaw were indicative of proper adhesion and good pad attachment.Based on the condition of the returned unit, the pad detachment was caused by adhesive failure.However, there was no evidence of a manufacturing defect.As a result, the exact root cause of the pad detachment is unknown.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: lower anterior colon resection.The account mgr was present for the case.Dr [name] was performing a lower anterior colon resection.The grasper was being used with the ctf03 trocar.He noticed that the jaws of the grasper were misaligned.He was not grabbing tissue at the time and had already placed the drain in the patient.He stated that he did not recollect when or how the jaw became misaligned.A new grasper was opened and the case was completed.There was no damage to the tissue.There was no patient injury.There are no photos available.The device is available to be returned.Intervention: replaced with a new grasper.Patient status: no patient injury.

• Brand Name: C4120, 38CM 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: 11478045
• MDR Text Key: 239794187
• Report Number: 2027111-2021-00383
• Device Sequence Number: 1
• Product Code: NWV
• UDI-Device Identifier: 00607915116866
• UDI-Public: (01)00607915116866(17)231112(30)01(10)1401643
• 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
• Report Date: 04/30/2021

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: 11/12/2023
• Device Model Number: C4120
• Device Catalogue Number: 101472471
• Device Lot Number: 1401643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/11/2021
• Initial Date FDA Received: 03/12/2021
• Supplement Dates Manufacturer Received: 03/11/2021
• Supplement Dates FDA Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CTF03 TROCAR