MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CY010, 5MMX35CM EPIX LAPA DISSECT, 10/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	CY010
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device is anticipated to return.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy during the case, one of the jaws broke off the dissector and fell into the patient.It is unknown when during the case this occurred.The dissector was used to dissect the cystic duct.No damage was noted on the dissector prior to the jaw breaking.The piece was retrieved from the patient.The case was completed with a new dissector.No patient injury.No photos are available.Product is available for return.Intervention: used new retrieval bag to complete case.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Engineering confirmed that one of the jaws had fractured.Further examination of the jaw did not reveal any porosity or voids at the fracture location.The shaft was also significantly bent.Based on the condition of the returned unit, it is likely that the jaw broke due a large force that was applied to the jaws.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy.During the case, one of the jaws broke off the dissector and fell into the patient.It is unknown when during the case this occurred.The dissector was used to dissect the cystic duct.No damage was noted on the dissector prior to the jaw breaking.The piece was retrieved from the patient.The case was completed with a new dissector.No patient injury.No photos are available.Product is available for return.Additional information received via email on (b)(6) 2021 from [name]: the exact date was not available.I was told it occurred approximately 2 weeks prior to the date i filed the cer.The dissector was being used to dissect the cystic duct.Intervention: used new retrieval bag to complete case.Patient status: no patient injury.

• Brand Name: CY010, 5MMX35CM EPIX LAPA DISSECT, 10/BX
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 11389154
• Report Number: 2027111-2021-00364
• Device Sequence Number: 4088503
• Product Code: GEI
• UDI-Device Identifier: 00607915126964
• UDI-Public: (01)00607915126964(17)230728(30)01(10)1392713
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K103282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2023
• Device Model Number: CY010
• Device Catalogue Number: 101419901
• Device Lot Number: 1392713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 05/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1