MAUDE Adverse Event Report: AMERICAN CONTRACT SYSTEMS, INC. GENERAL SURGICAL PROCEDURE KIT; LAPAROSCROPY KIT

Model Number	RCLC51A
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A hole in table cover was detected prior to use on patient; however, the surgical case had to be cancelled.Additional follow up questions have been requested; no responses have been received to-date.
Additional Manufacturer Narrative
The product involved in the event was not returned for evaluation.A follow-up report will be provided upon conclusion of investigation.This product incident is documented in the complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that product is defective or has caused serious injury.
Additional Manufacturer Narrative
Complaint photo was received and reviewed.Based on review of the photo, it appears the assembly teammate wrapped the pack too tight.Assembly team was retrained on as-04, wrapping techniques.When the pack is wrapped too tight it can cause components to poke through the wrap.A quality alert was issued and reviewed additionally with teammates for this complaint.The device history record was pulled and reviewed.No issues were found.The root cause is due to assembly teammate not paying close attention to detail.This product incident is documented in the complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that product is defective or has caused serious injury.

• Brand Name: GENERAL SURGICAL PROCEDURE KIT
• Common Device Name: LAPAROSCROPY KIT
• Manufacturer (Section D): AMERICAN CONTRACT SYSTEMS, INC.; 1601 se gateway drive; suite 120; grimes IA 50111
• Manufacturer (Section G): AMERICAN CONTRACT SYSTEMS, INC.; 1601 se gateway drive; suite 120; grimes IA 50111
• Manufacturer Contact: nichole early ; 1601 se gateway drive; suite 120; grimes, IA 50111 ; 8287820529
• MDR Report Key: 19615648
• Report Number: 3007069947-2024-00001
• Device Sequence Number: 6140712
• Product Code: FDE
• UDI-Device Identifier: 00191072204929
• UDI-Public: 00191072204929
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

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 Model Number: RCLC51A
• Device Catalogue Number: RCLC51A
• Device Lot Number: 892241
• 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: 06/13/2024
• Supplement Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown