MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTR73, 12X100 KII OPT ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number CTR73

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Patient Involvement (2645)

Event Date 11/20/2019

Event Type  malfunction  

Manufacturer Narrative

The event unit returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.

Event Description

Name of procedure being performed na (incoming inspection).Detailed description of event: olympus incoming inspection po# (b)(4).This is a complaint from aomori olympus evaluation team.The lot mentioned above was found to have defective units per our incoming inspection.Delivery date: november 18, 2019.We found defects as the result of incoming inspection of the products.Please refer to the attachment material for the quantity which returns the products.We found the defects that already informed applied medical by cer.We just inform you the defect and return the products for following defects.You do not need investigation.(1) foreign object in pouch - ctr73 lot# 1370334 (2 ea).Patient status: na.Type of intervention: na.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual inspection confirmed the presence of a plastic-like strand in the pouch seal.Based on the condition of the returned unit, it is likely that the plastic-like strand came from the clear side of the pouch and was embedded into the pouch seal during the packaging process.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

Event Description

Name of procedure being performed na (incoming inspection) detailed description of event: olympus incoming inspection po# (b)(4).This is a complaint from aomori olympus evaluation team.The lot mentioned above was found to have defective units per our incoming inspection.Delivery date: (b)(6) 2019.Please refer to the attachment file.We found defects as the result of incoming inspection of the products.Please refer to the attachment material for the quantity which returns the products.We found the defects that already informed applied medical by cer.We just inform you the defect and return the products for following defects.You do not need investigation.(1) foreign object in pouch - ctr73 lot# 1370334 (2 ea) patient status: na.Type of intervention: na.

• Brand Name: CTR73, 12X100 KII OPT ZTHR 6/BX
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 10280416
• MDR Text Key: 199490326
• Report Number: 2027111-2020-00505
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915123680
• UDI-Public: (01)00607915123680(17)220925(30)01(10)1370334
• Combination Product (y/n): N
• PMA/PMN Number: K060096
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/25/2022
• Device Model Number: CTR73
• Device Catalogue Number: 101219401
• Device Lot Number: 1370334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1