MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CNGL3, GELPOINT MINI ADV ACCESS PLATFORM; GCJ

Model Number	CNGL3
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device is anticipated to return.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Name of procedure being performed ni.Detailed description of event: "hi [name]: just want to let you know that i have a mini gelpoint cat# cngl3 at my desk from a case yesterday with dr.[name].Apparently a piece of it fell apart.I¿ve included dr.[name] in the email also in case she has some input on the sequence of events.Cat#: cngl3, lot#: 1343048, expiration date 12/02/2021." additional information was received via email on 03may2019 from [name], applied med, acct.Mgr.From dr.[name]."it was a clear plastic part from the port.It was free floating in the patient's abdomen.I'm glad that my pa noticed it and we removed it.I was able to continue the case ok." type of intervention: the "pa noticed it and we removed it.I was able to continue the case ok." patient status: no patient injury occurred associated with the event.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection of the returned unit confirmed the complainant¿s experience of seal component separation.Based on condition of the unit that was returned, the shield most likely dislodged as a result of non-axial insertion or removal of asymmetrical instrumentation through the sleeve.Applied medical's instructions for use (ifu) states that, "extra care should be used when inserting angular and asymmetrical instruments, such as 'j' hooks and clip appliers.All instruments should be centered axially when inserted through the seal to prevent tearing." this report is also a follow-up repot to medwatch 2000330000-2019-8032.
Event or Problem Description
Name of procedure being performed ni.Detailed description of event: "hi [name]: just want to let you know that i have a mini gelpoint cat# cngl3 at my desk from a case yesterday with dr.[name].Apparently a piece of it fell apart.I¿ve included dr.[name] in the email also in case she has some input on the sequence of events.Cat# cngl3 lot# 1343048 expiration date 12/02/2021" additional information was received via email on 03may2019 from [name], applied med, acct.Mgr.From dr.[name]."it was a clear plastic part from the port.It was free floating in the patient's abdomen.I'm glad that my pa noticed it and we removed it.I was able to continue the case ok." additional information was received via email on 09may2019 from , applied med, acct.Mgr.: "i had to send the product to our risk management department.I¿m including [name] since i can¿t remember the staff member in risk management that it got sent to.Either [name] or myself will forward your below information to them so that they can return it to you after their needs are met." medwatch 2000330000-2019-8032 received via mail on (b)(6) 2019: reporter: (b)(6).(b)(6) patient info: 53 yrs, male, 81 kg, not hispanic/latino.Preexisting characteristics that may have contributed to the event: hypertension.Date of event: may 2019.Internal part of the gelpoint mini advanced access platform fell out and into the abdominal cavity during procedure.Laparoscopic sigmoidectomy with primary colorectal anastomosis.Type of intervention: the "pa noticed it and we removed it.I was able to continue the case ok." patient status: no patient injury occurred associated with the event.

• Brand Name: CNGL3, GELPOINT MINI ADV ACCESS PLATFORM
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8660951
• Report Number: 2027111-2019-00462
• Device Sequence Number: 14028181
• Product Code: GCJ
• UDI-Device Identifier: 00607915131784
• UDI-Public: (01)00607915131784(17)211202(30)01(10)1343048
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K090275
• 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): 08/19/2019

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: 12/02/2021
• Device Model Number: CNGL3
• Device Catalogue Number: 101361901
• Device Lot Number: 1343048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/02/2019
• Supplement Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 05/31/2019
• Supplement Report FDA Received Date: 08/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 81