MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8402, M ALEXIS O WND PROT/RET 5/BX; RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL

Model Number	C8402
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is not anticipated to return to applied medical for evaluation.A follow-up will be provided upon completion of the investigation.This report is to follow-up medwatch # (b)(4).
Event or Problem Description
Procedure performed: laparoscopic ileocecectomy.Event description: complaint created based on medwatch received via email.Report number (b)(4)."during the procedure an alexis wound retractor was opened to be used, upon the surgeon unraveling the alexis wound retractor a small piece of plastic like material fell out.The foreign material was then placed in a specimen cup and removed off the field.Management was notified and the object was handed off to them." additional information was received via email on 24mar2023 from [name], quality coordinator, [name] hospital.When asked if any patient injury occurred the contact responded "not that i am aware of." patient status is "unknown".No instruments were used "at the time that this occurred.It was opened to use and the piece fell into the patient." all pieces were retrieved from the patient.When asked how the case was completed the response was "yes".When asked if the piece that fell into the patient was thin and clear like the sheath or if it was green or white like part of the rings the response was "it was made out of the material of the item"."we typically do not return devices.We kept package and the piece that fell off.The actual device was used on the patient." when asked if photos could be provided of the plastic piece the response was "it is in the locker, but we can".Additional information was received via email on 24mar2023 from [name], quality coordinator, [name] hospital."hello, i will be in the office mid week and can provide a photo.Would you be able to come on site to inspect as we typically do not return items.I¿ve also copied our patient safety manager who i work directly with for any medical device reports.Thank you." intervention: ni.Patient status: no patient injury."unknown".
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.This report is to follow-up medwatch # 3902670000-2023-8004.
Event or Problem Description
Procedure performed: laparoscopic ileocecectomy event description: complaint created based on medwatch received via email.Report number 3902670000-2023-8004."during the procedure an alexis wound retractor was opened to be used, upon the surgeon unraveling the alexis wound retractor a small piece of plastic like material fell out.The foreign material was then placed in a specimen cup and removed off the field.Management was notified and the object was handed off to them." additional information was received via email on (b)(6) 2023 from [name], quality coordinator, [name] hospital when asked if any patient injury occurred the contact responded "not that i am aware of." patient status is "unknown".No instruments were used "at the time that this occurred.It was opened to use and the piece fell into the patient." all pieces were retrieved from the patient.When asked how the case was completed the response was "yes".When asked if the piece that fell into the patient was thin and clear like the sheath or if it was green or white like part of the rings the response was "it was made out of the material of the item"."we typically do not return devices.We kept package and the piece that fell off- the actual device was used on the patient." when asked if photos could be provided of the plastic piece the response was "it is in the locker, but we can".Additional information was received via email on (b)(6)2023 from [name], quality coordinator, [name] hospital "hello, i will be in the office mid week and can provide a photo.Would you be able to come on site to inspect as we typically do not return items.I¿ve also copied our patient safety manager who i work directly with for any medical device reports.Thank you." intervention: ni patient status: no patient injury."unknown".

• Brand Name: C8402, M ALEXIS O WND PROT/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
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 16745275
• Report Number: 2027111-2023-00417
• Device Sequence Number: 6727039
• Product Code: KGW
• UDI-Device Identifier: 00607915117269
• UDI-Public: (01)00607915117269(17)250501(30)01(10)1450642
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2023

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: 05/01/2025
• Device Model Number: C8402
• Device Catalogue Number: 101356201
• Device Lot Number: 1450642
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2023
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Sex: Female