MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CNGL3, GELPOINT MINI ADV ACCESS PLATFORM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CNGL3
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The vent unit is anticipated to return for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Name of procedure being performed single incision laparoscopic cholecystectomy.Detailed description of event: product pouch is torn.The blister packaging was intact.Customer used the products in a procedure.From cer form: when opening the inner packaging it was recognized that the pouch was already torn.The parts of the device were taken out separately of the plastic blister and used.Additional information received from fitm by email on 06mar2020: the fitm discussed the case again with the or manager, who was quite sure that the pouch was torn at the moment they wanted to open it.They decided to have the product taken out of the blister by the sterile nurse.Additional information received from fitm by phone on 04mar2020: with "blister packaging", the tray inside the pouch is meant.The customer used the product because they did not realize that the tray is not a sterile barrier.Patient status: fine.Type of intervention: n/i.
Event or Problem Description
Name of procedure being performed single incision laparascopic cholecystectomy.Detailed description of event: product pouch is torn.The blister packaging was intact.Customer used the products in a procedure.From cer form: when opening the inner packaging it was recognized that the pouch was already torn.The parts of the device were taken out separately of the plastic blister and used.Additional information received from (b)(6) by email on 06mar2020: the (b)(6) discussed the case again with the operation room manager, who was quite sure that the pouch was torn at the moment they wanted to open it.They decided to have the product taken out of the blister by the sterile nurse.Additional information received from (b)(6) by phone on 04mar2020: with "blister packaging", the tray inside the pouch is meant.The customer used the product because they did not realize that the tray is not a sterile barrier.Patient status: fine.Type of intervention: n/i.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Upon visual inspection, engineering confirmed there was a tear in the pouch.Engineering observed that the mylar (clear) side of the pouch was torn.Applied medical has reviewed the details surrounding the event and the returned unit and is unable to determine the root cause of the event.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• Brand Name: CNGL3, GELPOINT MINI ADV ACCESS PLATFORM
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 9879317
• Report Number: 2027111-2020-00440
• Device Sequence Number: 596311
• Product Code: GCJ
• UDI-Device Identifier: 00607915131784
• UDI-Public: (01)00607915131784(17)210111(30)01(10)1314929
• Combination Product (Y/N): N
• Initial Reporter Country: WZ
• PMA/510(K) Number: K090275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2020

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: Health Professional
• Device Expiration Date: 01/11/2021
• Device Model Number: CNGL3
• Device Catalogue Number: 101361901
• Device Lot Number: 1314929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 03/25/2020
• Supplement Report FDA Received Date: 06/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1