MAUDE Adverse Event Report: AMERICAN CONTRACT SYSTEMS, INC. ACS; GENERAL SURGERY STERILE SUPPLY PACK

Model Number CDRO64F

Device Problems Product Quality Problem (1506); Material Separation (1562); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/15/2019

Event Type  malfunction  

Event Description

The carilion custom robotic drape within the pack tears easily.Robotic drape seam came apart on right side at the top of the drape at the patient's chest and split down the side of the patient.

• Brand Name: ACS
• Type of Device: GENERAL SURGERY STERILE SUPPLY PACK
• Manufacturer (Section D): AMERICAN CONTRACT SYSTEMS, INC.; 904 bethel circle; waunakee WI 53597
• MDR Report Key: 8581926
• MDR Text Key: 144135747
• Report Number: 8581926
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00191072046260
• UDI-Public: (01)00191072046260(17)191129(10)667181
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CDRO64F
• Device Lot Number: 667181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/17/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/06/2019
• Type of Device Usage: N
• Patient Sequence Number: 1