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

Model Number C4130

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2020

Event Type  malfunction  

Manufacturer Narrative

Applied medical has received the incident device, and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.

Event Description

Type of procedure performed: vnotes hysterectomy+bilateral salpingectomy.[name] was doing a vnotes case, and towards the end of the case on the screen we noticed the grasper was scissoring.The grasper was removed and she continued the case with a reusable grasper from the tray.The patient was no harmed.[name] was not concerned during or after the case.It was the first time she had seen this with the applied medical grasper.Patient status: patient is fine and completely unaffected.Type of intervention: product was replaced with another.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual inspection confirmed that grasper jaws were misaligned.Engineering also observed that the formed end of the rivet was coming out of place.Based on the condition of the returned unit, the reported event was caused by the formed end of the rivet that came out of place while the device was being used.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Applied medical continuously seeks to improve the form, function and ease of use of its products.As part of this process, applied medical is currently researching possible enhancements intended to further minimize the potential for this type of event to occur.

Event Description

Type of procedure performed: vnotes hysterectomy+bilateral salpingectomy.[name] was doing a vnotes case and towards the end of the case on the screen we noticed the grasper was scissoring.The grasper was removed and she continued the case with a reusable grasper from the tray.The patient was no harmed.[name] was not concerned during or after the case.It was the first time she had seen this with the applied medical grasper.Patient status: patient is fine and completely unaffected.Type of intervention: product was replaced with another.

• Brand Name: C4130, 5MMX35CM EPIX LATIS GRASP, 10/BX
• Type of Device: LAPAROCOPIC ACESSORIES, GYNECOLOGIC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 10722955
• MDR Text Key: 215353886
• Report Number: 2027111-2020-00592
• Device Sequence Number: 1
• Product Code: NWV
• UDI-Device Identifier: 00607915110147
• UDI-Public: (01)00607915110147(17)230326(30)01(10)1384391
• 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: 11/04/2020

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: 03/26/2023
• Device Model Number: C4130
• Device Catalogue Number: 101472876
• Device Lot Number: 1384391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/25/2020
• Initial Date FDA Received: 10/22/2020
• Supplement Dates Manufacturer Received: 11/03/2020
• Supplement Dates FDA Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1