MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0R50, 12X130 KII BALLOON BLNT TIP 6/BX; GCJ

Model Number	C0R50
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to return for evaluation.A follow-up report will be sent upon completion of the investigation.This report is to follow-up mw # (b)(4).
Event or Problem Description
Procedure performed: robot assisted hysterectomy, bilateral salpingectomy.Event description: medwatch report # (b)(4) received via mail on 06feb2019.Date of event: (b)(6) 2018."air seal detected.Hole found in balloon." device available for return."device failed (e.G.Broke, couldn't get it to work or stopped working);" other information about the patient that may have influenced the outcome of the event: "none.".
Event or Problem Description
Procedure performed: robot assisted hysterectomy, bilateral salpingectomy.Event description: medwatch report # (b)(4) received via mail on 06feb2019.Date of event: (b)(6) 2018 "air seal detected.Hole found in balloon." device available for return."device failed (e.G.Broke, couldn't get it to work or stopped working);" other information about the patient that may have influenced the outcome of the event: "none" patient status: ni.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience of a hole in the balloon.Based on the condition of the returned unit, it is likely the reported event was caused by an instrument or object that came in contact with the balloon during the procedure.The instructions for use (ifu) states, "do not allow sharp instruments or objects to come into contact with balloon.Use caution around metal clamps, staple lines and during secondary port placement." applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.This event is not reportable as it is unlikely to cause or contribute to death or serious injury.This report is to follow-up medwatch # (b)(4).

• Brand Name: C0R50, 12X130 KII BALLOON BLNT TIP 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8364434
• Report Number: 2027111-2019-00352
• Device Sequence Number: 1921309
• Product Code: GCJ
• UDI-Device Identifier: 00607915116460
• UDI-Public: (01)00607915116460(17)210326(30)01(10)1320368
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K060629
• 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): 04/04/2019

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: 03/26/2021
• Device Model Number: C0R50
• Device Catalogue Number: 101451901
• Device Lot Number: 1320368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/06/2019
• Supplement Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 04/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR