MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CORPORATION ALEXIS LAPAROSCOPIC SYSTEM SMALL RIGID DISPOSABLE WOUND RETRACTOR; DRAPE, SURGICAL

Model Number	C8501 SMALL
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The alexis laparoscopic small wound retractor c8501 has a triangular shaped piece that is attached to the main body of the retractor by a [invalid].During a laparoscopic abdominal procedure, it was recognized that the triangular piece was missing from the [invalid].The knot attaching the triangular piece had apparently came undone.At the time it was recognized, the retractor was still in the body.There was concern for a retained foreign body in the surgical site.The item is not radiopaque.The piece was eventually found in the drapes but concern for future use and risk of foreign body retention, especially when not radiopaque, remains.(note that the representative did say it would be seen on mri.) fda safety report id #(b)(4).

• Brand Name: ALEXIS LAPAROSCOPIC SYSTEM SMALL RIGID DISPOSABLE WOUND RETRACTOR
• Common Device Name: DRAPE, SURGICAL
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES CORPORATION
• MDR Report Key: 15470454
• Report Number: MW5112223
• Device Sequence Number: 12734483
• Product Code: KKX
• UDI-Device Identifier: 00607915119928
• UDI-Public: (01)00607915119928(17)250427(30)
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/20/2022

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: 04/27/2025
• Device Model Number: C8501 SMALL
• Device Lot Number: 1449995
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/22/2022
• 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: Other
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White