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

Model Number C4120

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 09/30/2021

Event Type  malfunction  

Manufacturer Narrative

The event unit returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.

Event Description

Name of procedure being performed: lower anterior resection colectomy detailed description of event: information received via telephone (b)(6) 2021 from [name], account manager associate: a portion blue padding was noted to come of the jaws of a grasper during lower anterior resection polypectomy.After handling a section of colon tissue, the surgeon released the handles of the grasper and noticed a portion of a blue pad separated from the jaws.The pad did not detach from the jaws entirely, nor did it rip or tear.The surgeon proceeded to finish the procedure with another c4120 from a different lot number.There was no report of patient injury.Product is available for return.Lot traces to account (b)(6).Patient status: no report of patient injury.Type of intervention: surgeon used another c4120, different lot number.

Event Description

Name of procedure being performed: lower anterior resection colectomy.Detailed description of event: -information received via telephone (b)(6) 2021 from [name], account manager associate: a portion blue padding was noted to come of the jaws of a grasper during lower anterior resection polypectomy.After handling a section of colon tissue, the surgeon released the handles of the grasper and noticed a portion of a blue pad separated from the jaws.The pad did not detach from the jaws entirely, nor did it rip or tear.The surgeon proceeded to finish the procedure with another c4120 from a different lot number.-there was no report of patient injury.-product is available for return.-lot traces to account id (b)(4).Patient status: no report of patient injury.Type of intervention: surgeon used another c4120, different lot number.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual inspection confirmed one of the latis pads was partially detached from the jaw.Based on the evaluation of the returned unit, it is likely that the reported event was caused by adhesive failure.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• 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
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 12715933
• MDR Text Key: 282573101
• Report Number: 2027111-2021-00697
• Device Sequence Number: 1
• Product Code: NWV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/06/2021

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 Model Number: C4120
• Device Catalogue Number: 101472471
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/30/2021
• Initial Date FDA Received: 10/28/2021
• Supplement Dates Manufacturer Received: 09/30/2021
• Supplement Dates FDA Received: 12/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: LIGASURE ADVANCED L-HOOK