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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C4120, 38CM GRASPER REPOS CART, 10/BX; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
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APPLIED MEDICAL RESOURCES C4120, 38CM GRASPER REPOS CART, 10/BX; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC Back to Search Results
Model Number C4120
Device Problem Material Frayed (1262)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/03/2021
Event Type  malfunction  
Manufacturer Narrative
No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
 
Event Description
Procedure performed: lap lar.Event description: about 3 hours into the case, the surgeon noticed that the pad of the grasper looked like it was "fraying".No pieces of the pad fell off into the patient.The device was swapped out for a new grasper and the case was completed without further issue.There was no patient injury.There are no photos available.The device is available to be returned.Additional information received via email on 09jun2021 from applied medical team member: "i followed back up with the customer and the graspers accidentally got thrown away.I was unable to get a picture of them before this occurred." additional information received via email on 09jun2021 from applied medical team member: when asked if other devices were used around the grasper, responded "i don¿t believe so (wasn¿t in the room when it started to fray).However the surgeon was using a sonicision during the case." intervention: the device was swapped out for a new grasper and the case was completed without further issue.Patient status: no patient injury.
 
Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any damages or non-conformances that could have contributed to the reported event.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.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: lap lar.Event description: about 3 hours into the case, the surgeon noticed that the pad of the grasper looked like it was "fraying".No pieces of the pad fell off into the patient.The device was swapped out for a new grasper and the case was completed without further issue.There was no patient injury.There are no photos available.The device is available to be returned.Additional information received via email on 09jun2021 from applied medical team member: "i followed back up with the customer and the graspers accidentally got thrown away.I was unable to get a picture of them before this occurred." additional information received via email on 09jun2021 from applied medical team member: when asked if other devices were used around the grasper, responded "i don¿t believe so (wasn¿t in the room when it started to fray).However the surgeon was using a sonicision during the case." intervention: the device was swapped out for a new grasper and the case was completed without further issue.Patient status: no patient injury.
 
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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 Key12077042
MDR Text Key261909295
Report Number2027111-2021-00547
Device Sequence Number1
Product Code NWV
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/11/2021
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 NumberC4120
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/03/2021
Initial Date FDA Received06/28/2021
Supplement Dates Manufacturer Received06/03/2021
Supplement Dates FDA Received08/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SONICISION
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