MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES SC8XX2, GELPORT 120MM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	SC8XX2
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Name of procedure being performed laparoscopic sigmoid hand-assisted colon resection.Detailed description of event: limited information was available at the time of the report."gel plastic wound protector part that goes inside the patient ripped and completely broke off from the ring while insufflated inside the patient." additional information received via email on 21sep2020 from [name]: no patient injury occurred.Patient is fine.The tear occurred 1-2 hrs into the procedure.The sheath tore in one piece tear all hanging off together, no pieces.Graspers were being used at the time, no where near handport.Trocars and instruments were not placed directly through the gelport.Patient status: fine.Type of intervention: anp.
Event or Problem Description
Name of procedure being performed laparoscopic sigmoid hand-assisted colon resection detailed description of event: limited information was available at the time of the report."gel plastic wound protector part that goes inside the patient ripped and completely broke off from the ring while insufflated inside the patient." additional information received via email on (b)(6)2020 from [name]: no patient injury occurred.Patient is fine.The tear occurred 1-2 hrs into the procedure.The sheath tore in one piece tear all hanging off together, no pieces.Graspers were being used at the time, no where near handport.Trocars and instruments were not placed directly through the gelport.Patient status: fine type of intervention: anp.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Upon visual inspection, engineering confirmed that there was a tear in the sheath.Engineering also observed that a portion of the sheath was slightly stretched and had uneven cuts.Applied medical is unable to determine the root cause of the reported event based on the evaluation of the returned unit.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Correction was made to d4 - expiration date as it was provided incorrectly in the initial report.

• Brand Name: SC8XX2, GELPORT 120MM
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 10677899
• Report Number: 2027111-2020-00580
• Device Sequence Number: 3312545
• Product Code: GCJ
• UDI-Device Identifier: 00607915118303
• UDI-Public: (01)00607915118303(17)230407(30)01(10)1384995
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K014047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2020

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: 04/07/2023
• Device Model Number: SC8XX2
• Device Catalogue Number: 101473851
• Device Lot Number: 1384995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 12/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1