MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8405, XXL ALEXIS O WND PRO/RET 5/BX; RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL

Model Number	C8405
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	09/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product is being returned for evaluation but the lot number is provided.A device history report is to be reviewed by engineering.A follow-up report will be provided upon completion of the evaluation.
Event or Problem Description
Name of procedure being performed: hipec ex lap.Detailed description of event: additional information received via email on 17oct2019 from applied medical health systems specialist: the date an applied team member was made aware of the event was 10/17/19.The customer account # (b)(6).The facility name is [name]hospital.The date of the event was (b)(6) 2019.The model # was c8405.The lot# was 1358099.The procedure being performed was a hipec ex lap.The description of the event was: pt has neuropathy post op.The case was completed with alexis o and book walter.The patient status is neuropathy.The concomitant devices used with the alexis were book walter and hand held metal retractors.The surgeon/or team used alexis used multiple times since incident with no issues.Did not answer the question asked which was had they used it before.There were no issues with the alexis that lead them to use the retractor with the alexis.They use the book walter to elevate the abdomen for exposure.The surgeon did sweep bowels around inner ring before rolling down alexis.The device is not available to be returned, it was discarded by facility.Patient status: patient has neuropathy post op.Type of intervention: completed with alexis o and book walter.
Event or Problem Description
Name of procedure being performed: hipec ex lap.Detailed description of event: additional information received via email on 17oct2019 from applied medical health systems specialist: the date an applied team member was made aware of the event was 10/17/19.The customer account # (b)(4).The facility name is [name]hospital.The date of the event was (b)(6) 2019.The model # was c8405.The lot# was 1358099.The procedure being performed was a hipec ex lap.The description of the event was: pt has neuropathy post op.The case was completed with alexis o and book walter.The patient status is neuropathy.The concomitant devices used with the alexis were book walter and hand held metal retractors.The surgeon/or team used alexis used multiple times since incident with no issues.Did not answer the question asked which was had they used it before.There were no issues with the alexis that lead them to use the retractor with the alexis.They use the book walter to elevate the abdomen for exposure.The surgeon did sweep bowels around inner ring before rolling down alexis.The device is not available to be returned, it was discarded by facility.Additional information received via email on 18oct2019 from , applied medical health systems specialist: not able to know when it occurred in the procedure.Surgeon is assuming after alexis-o and metal retractors were put in place.The surgeon deployed the alexis-o, placed book walter on top of alexis-o, and managed book walter/metal retractors throughout procedure.Not able to know exactly when the event occurred during the procedure.Very first time surgeon and fa used alexis-o.Patient status: patient has neuropathy post op.Type of intervention completed with alexis o and book walter.
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.In the absence of the event unit, it is difficult to determine the exact root cause of the event.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the injury or confirm that a product malfunction occurred.

• Brand Name: C8405, XXL ALEXIS O WND PRO/RET 5/BX
• Common Device Name: RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 9216618
• Report Number: 2027111-2019-00617
• Device Sequence Number: 11394026
• Product Code: KGW
• UDI-Device Identifier: 00607915127190
• UDI-Public: (01)00607915127190(17)220616(30)01(10)1358099
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 11/11/2019

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: 06/16/2022
• Device Model Number: C8405
• Device Catalogue Number: 101356501
• Device Lot Number: 1358099
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/17/2019
• Supplement Date Received by Manufacturer: 10/17/2019
• Initial Report FDA Received Date: 10/21/2019
• Supplement Report FDA Received Date: 11/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BOOK WALTER AND HAND HELD METAL RETRACTORS
• Outcome Attributed to Adverse Event: Other