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	11/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit returned 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.Detailed description of event: this is a complaint from [name] evaluation team.The lot mentioned above was found to have defective units per our incoming inspection.Delivery date: november 18, 2019.Please refer to the attachment file.Per 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." "i) we found the two recurrence defects.We would like you to investigate the cause of this issue and would like you to have corrective action for following defects (1) insufficient heat sealing." patient status: na (incoming inspection).Type of intervention: na.
Event or Problem Description
Name of procedure being performed: na.Detailed description of event: this is a complaint from [name] evaluation team.The lot mentioned above was found to have defective units per our incoming inspection.Delivery date: november 18, 2019.Please refer to the attachment file.Per 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."."i) we found the two recurrence defects.We would like you to investigate the cause of this issue and would like you to have corrective action for following defects (1) insufficient heat sealing".Patient status: na (incoming inspection).Type of intervention: na.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of seal delamination.Based on the condition of the returned unit , it is likely that the seal delamination was caused by the rotary cutter that jammed during the packaging process.The jam caused the seals to open due to the stress that was applied to the seal prior to 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 continuously seeks to improve the form, function and ease of use of its products.As part of this process, applied medical is implementing process enhancements intended to further minimize the potential for this type of event to occur.This event is not reportable as it is unlikely to cause or contribute to death or serious injury and was reported in error.

• 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: 9468907
• Report Number: 2027111-2019-00666
• Device Sequence Number: 1834171
• Product Code: GCJ
• UDI-Device Identifier: 00607915116460
• UDI-Public: (01)00607915116460(17)220918(30)01(10)1368290
• 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): 03/06/2020

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: 09/18/2022
• Device Model Number: C0R50
• Device Catalogue Number: 101451901
• Device Lot Number: 1368290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 03/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1