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

Model Number	C0H11
Medical Device Problem Codes	Material Protrusion/Extrusion (2979); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Peritoneal Laceration(s) (2003); Excessive Tear Production (2235)
Date of Event	02/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: laparoscopic inguinal hernia.Event description: the rep was informed that the product sheared the peritoneum on the side and ruined the exposure.There was a delay in the or and the case was completed transabdominally.It is unknown if there were any issues with the balloon inflation.Additional information received via email on 05feb2021 from applied medical representative: patient is fine tissue was torn in the preperitoneal space and case had to be done differently the surgeon had a clear view through the scope.The surgeon did not attempt to move the balloon while it was inflated.The balloon was not deployed in the wrong direction.The seal housing was not removed at any point prior to the procedure.No photos or videos are available of the complaint event or product.Intervention: tissue was torn in the preperitoneal space and case had to be done differently, delay in the or, case was completed transabdominally.Patient status: tissue was torn in the preperitoneal space and case had to be done differently, patient is fine.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Engineering observed stretch marks on both sides of the balloon.Engineering also inflated the balloon and observed that the balloon was malformed.Based on the evaluation of the returned unit, it is likely that the balloon malformation was caused by a scope or introducer that was manipulated inside the balloon.It is possible that malformed balloon caused the torn tissue.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
Procedure performed: laparoscopic inguinal hernia.Event description: the rep was informed that the product sheared the peritoneum on the side and ruined the exposure.There was a delay in the or and the case was completed transabdominally.It is unknown if there were any issues with the balloon inflation.Additional information received via email on 05feb2021 from applied medical representative: patient is fine.Tissue was torn in the preperitineal space and case had to be done differently the surgeon had a clear view through the scope.The surgeon did not attempt to move the balloon while it was inflated.The balloon was not deployed in the wrong direction.The seal housing was not removed at any point prior to the procedure.No photos or videos are available of the complaint event or product.Intervention: tissue was torn in the preperitineal space and case had to be done differently, delay in the or, case was completed transabdominally.Patient status: tissue was torn in the preperitineal space and case had to be done differently, patient is fine.

• 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: 11317815
• Report Number: 2027111-2021-00327
• Device Sequence Number: 3335160
• Product Code: GCJ
• UDI-Device Identifier: 00607915136703
• UDI-Public: (01)00607915136703(17)231008(30)01(10)1399294
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K182024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2021

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: 10/08/2023
• Device Model Number: C0H11
• Device Catalogue Number: 101474193
• Device Lot Number: 1399294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention