MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0H11, KII DISSECTING BALLOON, OVL, 3/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	C0H11
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Blood Loss (2597)
Date of Event	08/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: tep hernia.Event description: the inflation pump of the kii dissecting balloon detached involuntarily multiple times (~6) during attempted inflation, meaning a reasonable amount of air could not be administered, and each time this happened the inflation was lost.There is no fixation method, nor is closing the stopcock an option, as it was involuntarily removed so there is no time to close the stopcock.The surgeon also only has one hand to perform this function, with the other holding the trocar.The kii dissecting balloon was also inserted too far into the patient's pre-peritoneal space.The surgeon complained it was not clear to identify correct placement.This led to associated damage to the internal structures, bleeding and bruising, as he advanced beyond the pubic symphysis.He mentioned the [competitor device] was much easier to place correctly and easier to visualise the correct placement.The surgeon did mention the injury was possibly due to his inexperience with the device, but that it was difficult to identify correct placement.Additional information received from regional field implementation team member by email on 22aug2019: after the balloon had been inserted too far, the surgeon proceeded with the space created by the dissecting balloon and manipulation / instrument dissection.He did not use another device.The sheath was not opened prior to use.The balloon was inflated under direct visualization.The device was inserted and inflated with the stopcock oriented upward.The patient's anatomy from umbilicus to pubic symphysis did not significantly vary from an average adult size.Patient status: anticipated bruising.Intervention: pre-peritoneal space created by manipulation / instrument dissection.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and the complainant¿s experience could not be replicated or confirmed.In the absence of the event unit, it is difficult to determine the exact root cause of the event.At this time, applied medical is unable to determine the root cause of the event or confirm that a product malfunction occurred.
Event or Problem Description
Procedure performed: tep hernia.Event description: the inflation pump of the kii dissecting balloon detached involuntarily multiple times (~6) during attempted inflation, meaning a reasonable amount of air could not be administered, and each time this happened the inflation was lost.There is no fixation method, nor is closing the stopcock an option, as it was involuntarily removed so there is no time to close the stopcock.The surgeon also only has one hand to perform this function, with the other holding the trocar.The kii dissecting balloon was also inserted too far into the patient's pre-peritoneal space.The surgeon complained it was not clear to identify correct placement.This led to associated damage to the internal structures, bleeding and bruising, as he advanced beyond the pubic symphysis.He mentioned the [competitor device] was much easier to place correctly and easier to visualise the correct placement.The surgeon did mention the injury was possibly due to his inexperience with the device, but that it was difficult to identify correct placement.Additional information received from regional field implementation team member by email on 22aug2019: after the balloon had been inserted too far, the surgeon proceeded with the space created by the dissecting balloon and manipulation / instrument dissection.He did not use another device.The sheath was not opened prior to use.The balloon was inflated under direct visualization.The device was inserted and inflated with the stopcock oriented upward.The patient's anatomy from umbilicus to pubic symphysis did not significantly vary from an average adult size.Patient status: anticipated bruising.Intervention: pre-peritoneal space created by manipulation / instrument dissection.

• Brand Name: C0H11, KII DISSECTING BALLOON, OVL, 3/BX
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 9008778
• Report Number: 2027111-2019-00584
• Device Sequence Number: 19452152
• Product Code: GCJ
• UDI-Device Identifier: 00607915136703
• UDI-Public: (01)00607915136703(17)220109(30)01(10)1346532
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K182024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/09/2022
• Device Model Number: C0H11
• Device Catalogue Number: 101471172
• Device Lot Number: 1346532
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/16/2019
• Supplement Date Received by Manufacturer: 08/16/2019
• Initial Report FDA Received Date: 09/12/2019
• Supplement Report FDA Received Date: 10/11/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other