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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C4130, 5MMX35CM EPIX LAPA GRASPER, 10/BX; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
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APPLIED MEDICAL RESOURCES C4130, 5MMX35CM EPIX LAPA GRASPER, 10/BX; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC Back to Search Results
Model Number C4130
Device Problems Fracture (1260); Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/09/2022
Event Type  malfunction  
Event Description
Procedure performed: "lap appy".Event description: rep was not there for the case.All they heard from the hospital contact was that "graspers were broken".The rep was unable to attain any more information beyond that the item was discarded and the packing was thrown out as well.Additional information was received via email on 18nov2022 from [name], account manager ii, applied medical: "the graspers developed a split in the shaft near the graspers jaws.At which point the graspers remained shut.Dr.[name] used a pair of scissors to pry the graspers open.They threw the graspers away and opened another pair of graspers and proceeded to finish the procedure." product not available for return.Intervention: "dr.[name] used a pair of scissors to pry the graspers open.They threw the graspers away and opened another pair of graspers".Patient status: "no patient injury".
 
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 appy".Event description: rep was not there for the case.All they heard from the hospital contact was that "graspers were broken".The rep was unable to attain any more information beyond that the item was discarded and the packing was thrown out as well.Additional information was received via email on 18nov2022 from [name], account manager ii, applied medical: "the graspers developed a split in the shaft near the graspers jaws.At which point the graspers remained shut.Dr.[name] used a pair of scissors to pry the graspers open.They threw the graspers away and opened another pair of graspers and proceeded to finish the procedure." product not available for return.Intervention: "dr.[name] used a pair of scissors to pry the graspers open.They threw the graspers away and opened another pair of graspers".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 non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.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 the harm resulting from this failure have been evaluated and were found to be at an acceptable level.
 
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Brand Name
C4130, 5MMX35CM EPIX LAPA GRASPER, 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 Key15919261
MDR Text Key307905171
Report Number2027111-2022-00846
Device Sequence Number1
Product Code NWV
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/12/2023
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 NumberC4130
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/18/2022
Initial Date FDA Received12/05/2022
Supplement Dates Manufacturer Received11/18/2022
Supplement Dates FDA Received01/12/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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