MAUDE Adverse Event Report: DEROYAL CMC LAPAROSCOPY PACK; GENERAL SURGERY TRAY

Catalog Number 89-10561.01

Device Problems Contamination (1120); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2021

Event Type  malfunction  

Event Description

Setting up for laparoscopic cholecystectomy.Opened 4 different deroyal laparoscopy packs.Hairs, specks and different issues in all 4 packs.3 packs and pack lists secured for quality.1 pack list and items saved for quality.Pack 1: hair in basin, secured with tape, floaters in white bowl.Pack 2: brown specks on light handle covers.Pack 3: brown specks on light handle covers.Pack 4: white flakes in bottom of white basin, dark specks on outside cover of light handle.Secured just these 2 items to take to quality.Packs and pack sheets will be taken to quality.Made decision to not open any more of these packs and opened a back table cover and separate items needed for case to decrease additional delay time.Approximate room delay from set up to patient in room of 37 mins.Patient remained in hall while packs were transported in and out of room.Saved items - basin from pack 1 with hair (taped), white basin with white flakes taped to basin from pack 4, and light handles with dark specks (taped to dome side) from pack 2 & 3.

• Brand Name: CMC LAPAROSCOPY PACK
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): DEROYAL; 200 debusk lane; powell TN 37849
• MDR Report Key: 11737092
• MDR Text Key: 247697966
• Report Number: 11737092
• Device Sequence Number: 1
• Product Code: LRO
• 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: 03/17/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 89-10561.01
• Device Lot Number: 53817313
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/17/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/28/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 5110 DA