MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8403, L ALEXIS O WND PROT/RET 5/BX

Model Number	C8403
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned for evaluation but lot # is provided.A device history report is to be reviewed by engineering.A final report will be sent once the results have been analyzed.
Event or Problem Description
"ovarian cystectomy - during initial placement of the alexis the retraction ring itself became detached at the connection area while being rolled down.[surgeon] was the gynecologist using the product during the incident." type of intervention - "a second c8403 was used to complete the procedure." patient status - "no issues.".
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.In the absence of the subject device, it is difficult to determine the root cause of the event.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.
Event or Problem Description
Additional information received via email from applied medical team member, february 28, 2017: there was no negative impact on the patient from the alexis ring becoming detached.The surgeon was very familiar with the previous alexis flexible and had the local tma support his first case using the alexis ridged.The staff had been inserviced prior to the product upgrade, had additional inservicing prior to each case where the ridged was used by the surgeon the first time, and was re-inserviced following the cer.The condition of the sheath was intact following the separation of the ring.There shouldn't have been any instrumentation that came into contact with the ring because the ring becoming detached occurred at the very beginning of the procedure while it was being placed into the abdomen.The tma spoke with the surgeon today and found out that the surgeon had accidentally squeezed the wrong ring.He squeezed the white rigid ring thinking it was the insertion ring and so broke it with his bare hands.

• Brand Name: C8403, L ALEXIS O WND PROT/RET 5/BX
• Common Device Name: ALEXIS
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6380728
• Report Number: 2027111-2017-01453
• Device Sequence Number: 779895
• Product Code: KGW
• UDI-Device Identifier: 00607915117276
• UDI-Public: (01)00607915117276(17)190929(30)01(10)1279987
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K041711
• 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): 04/26/2017

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: Other
• Device Expiration Date: 09/29/2019
• Device Model Number: C8403
• Device Catalogue Number: 101356301
• Device Lot Number: 1279987
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2017
• Supplement Report FDA Received Date: 04/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1