MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C4130, 5MMX35CM EPIX LATIS GRASP, 10/BX; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Model Number	C4130
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned for evaluation but lot # is provided.A device history report is to be reviewed by engineering.A follow up report will be sent once the results have been analyzed.
Event or Problem Description
Procedure performed: lap chole.Cer 1 of 2: (b)(4).Cer 2 of 2: (b)(4).Graspers jaws were locked on gallbladder but the grasper would not unlock.Jaws were unlocked after several grip actions.Grasper was discarded & new epix grasper was used with which they had a very similar experience (seperate cer).This epix grasper had the same lotnumber.Intervention: change of device.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and the complainant¿s experience could not be replicated or confirmed.In the absence of the event unit, it is difficult 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 or Problem Description
Procedure performed: lap chole.Cer 1 of 2: (b)(4).Cer 2 of 2: (b)(4).A second epix grasper with same lotnumber was used after issues with the first one that was used (see precious cer of same date).Epix grasper jaws were locked on the gallbladder, experienced difficulty to unlock the jaws.After several grip actions they succeeded to unlock the jaws.Intervention: unknown.Patient status: no patient injury.

• Brand Name: C4130, 5MMX35CM EPIX LATIS GRASP, 10/BX
• Common Device Name: LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 10708579
• Report Number: 2027111-2020-00587
• Device Sequence Number: 3645314
• Product Code: NWV
• UDI-Device Identifier: 00607915110147
• UDI-Public: (01)00607915110147(17)230428(30)01(10)1385180
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2020

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: 04/28/2023
• Device Model Number: C4130
• Device Catalogue Number: 101472876
• Device Lot Number: 1385180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1