MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C4119, 32CM GRASPER REPOS CART, 10/BX; NWV

Model Number 1

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/11/2017

Event Type  malfunction  

Manufacturer Narrative

The incident device is anticipated to return.A follow-up report will be provided upon completion of the investigation.

Event Description

Procedure performed: unknown.Incident description: (b)(4) incident reported by email by clinical procurement.Details of the complaint listed as "the blue pad from the tip of the grasper came off".Patient status: unknown.Type of intervention: unknown.

Manufacturer Narrative

Investigation summary: the event unit was returned for evaluation.Visual inspection confirmed the complainant's experience of pad detachment.Based on the condition of the returned unit, it is likely that the reported event was caused during manufacturing, either from a lack of adhesive or from repositioning or readjusting the pad during curing.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.

• Brand Name: C4119, 32CM GRASPER REPOS CART, 10/BX
• Type of Device: NWV
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: wendy kobayashi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138059
• MDR Report Key: 6793276
• MDR Text Key: 82791916
• Report Number: 2027111-2017-01935
• Device Sequence Number: 1
• Product Code: NWV
• UDI-Device Identifier: 00607915116859
• UDI-Public: (01)00607915116859(17)191214(30)01(10)1285427
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: 1
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/06/2017

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: Other
• Device Expiration Date: 12/14/2019
• Device Model Number: 1
• Device Catalogue Number: 1
• Device Lot Number: 1285427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/24/2017
• Initial Date FDA Received: 08/14/2017
• Supplement Dates Manufacturer Received: 07/24/2017
• Supplement Dates FDA Received: 10/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1