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	08/13/2019
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: hand assisted laparoscopic sigmoid colectomy with a pfannenstiel incision.Detailed description of event: surgeon: dr.[name].Complaint: the sheath on the alexis retractor on the gelport broke.A picture is attached.Customer would like a credit for one gelport and has the product available to ship back but they threw away packaging and do not know lot number.Additional information received from applied medical account manager, via e-mail on august 14th, 2019: i was not present for the case.No patient injury or illness.Patient was fine.Don¿t know patient demographics, surgeon said it was a straightforward case that was nothing special.Another gelport was opened and case completed after first gelport alexis sheath broke.Only the hand was placed through the gelport.Tear occurred when surgeon removed his hand during the procedure.Tear occurred during the procedure and not upon placement.Device was removed and replaced case was a hand assisted laparoscopic sigmoid colectomy with a pfannenstiel incision.Patient status: patient was fine.Type of intervention: another gelport was opened and case completed after first gelport alexis sheath broke.
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.A stretch mark was observed near the sheath tear.Based on the condition of the returned unit and the event description, the exact root cause of the event could not be determined.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Name of procedure being performed: hand assisted laparoscopic sigmoid colectomy with a pfannenstiel incision.Detailed description of event: surgeon: dr.[name] complaint: the sheath on the alexis retractor on the gelport broke.A picture is attached.Customer would like a credit for one gelport and has the product available to ship back but they threw away packaging and do not know lot number.Additional information received from applied medical account manager, via e-mail on august 14th, 2019: i was not present for the case.No patient injury or illness.Patient was fine.Don¿t know patient demographics, surgeon said it was a straightforward case that was nothing special.Another gelport was opened and case completed after first gelport alexis sheath broke.Only the hand was placed through the gelport.Tear occurred when surgeon removed his hand during the procedure.Tear occurred during the procedure and not upon placement.Device was removed and replaced case was a hand assisted laparoscopic sigmoid colectomy with a pfannenstiel incision.Patient status: patient was fine.Type of intervention another gelport was opened and case completed after first gelport alexis sheath broke.

• 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: 8961144
• Report Number: 2027111-2019-00575
• Device Sequence Number: 16858803
• Product Code: GCJ
• UDI-Device Identifier: 00607915118303
• UDI-Public: (01)00607915118303(17)220421(30)01(10)1355120
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 09/24/2019

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: 04/21/2022
• Device Model Number: SC8XX2
• Device Catalogue Number: 101473851
• Device Lot Number: 1355120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 09/04/2019
• Supplement Report FDA Received Date: 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1