MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0R50, 12X130 KII BALLOON BLNT TIP 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	C0R50
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Name of procedure being performed: na (incoming inspection).Detailed description of event: olympus incoming inspection po# 152p036d.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: may 27, 2020.We found defect as the result of incoming inspection of the products.Please refer to the attachment material for the quantity which return the product.Pouch torn - c0r50 lot# 1383014 (1 ea.).Patient status: na (incoming inspection).Type of intervention: na.
Event or Problem Description
Name of procedure being performed: na (incoming inspection).Detailed description of event: [name] incoming inspection po# (b)(4).This is a complaint from [name] evaluation team.The lot mentioned above was found to have defective units per our incoming inspection.Delivery date: may 27, 2020.Please refer to the attachment file.We found defect as the result of incoming inspection of the products.Please refer to the attachment material for the quantity which return the product.Pouch torn - c0r50 lot# 1383014 (1 ea.).Patient status: na (incoming inspection).Type of intervention: na.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Upon visual inspection, engineering confirmed that there was a hole on the clear side of the pouch.Engineering also observed scratch and scuffs near the location of the hole.Based on the condition of the returned unit, the hole in the pouch was caused by contact with an object, which likely occurred during shipping and handling.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• Brand Name: C0R50, 12X130 KII BALLOON BLNT TIP 6/BX
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 10258598
• Report Number: 2027111-2020-00499
• Device Sequence Number: 19483712
• Product Code: GCJ
• UDI-Device Identifier: 00607915116460
• UDI-Public: (01)00607915116460(17)230317(30)01(10)1383014
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K060629
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2020

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: No Information
• Device Expiration Date: 03/17/2023
• Device Model Number: C0R50
• Device Catalogue Number: 101451901
• Device Lot Number: 1383014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 06/16/2020
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 09/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1