MAUDE Adverse Event Report: PACK ROOM LLC HUNTSVILLE LAP CHOLE; LAPAROSCOPY KIT

Model Number HH270

Device Problems Component Missing (2306); Packaging Problem (3007)

Patient Problem Insufficient Information (4580)

Event Date 04/15/2022

Event Type  malfunction  

Event Description

Case cart arrived with a cystoscopy pack instead of a lap chole pack.Staff pulled lap chole pack from shelf and there was only 4 laps inside instead of 5.Also there was no insufflation tubing product.Manufacturer response for laparoscopic cholecystectomy pack, huntsville lap chole (per site reporter) no response has been received at this time.

• Brand Name: HUNTSVILLE LAP CHOLE
• Type of Device: LAPAROSCOPY KIT
• Manufacturer (Section D): PACK ROOM LLC; 1281 highway 155 south; mc donough GA 30253
• MDR Report Key: 14186199
• MDR Text Key: 289872300
• Report Number: 14186199
• Device Sequence Number: 1
• Product Code: FDE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: HH270
• Device Catalogue Number: HH270.001
• Device Lot Number: 31201
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/20/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1