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

Model Number C4130

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2020

Event Type  malfunction  

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 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.

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 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
• Type of Device: LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 10708579
• MDR Text Key: 213685537
• Report Number: 2027111-2020-00587
• Device Sequence Number: 1
• Product Code: NWV
• UDI-Device Identifier: 00607915110147
• UDI-Public: (01)00607915110147(17)230428(30)01(10)1385180
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 10/05/2020
• Initial Date FDA Received: 10/20/2020
• Supplement Dates Manufacturer Received: 10/05/2020
• Supplement Dates FDA Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1