MAUDE Adverse Event Report: W.O.M. WORLD OF MEDICINE GMBH PNEUMOCLEAR HEATED HUMIDIFIED SMOKE EVACUATION TUBE SET; CARBON DIOXIDE INSUFFLATOR FOR LAPAROSCOPY AND VESSEL HARVESTING

Model Number ST298

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 07/18/2023

Event Type  malfunction  

Event Description

We have been informed of the following event: "when she open the box she noticed the tube set had a hole in it".Problem description product #: 620050350.Serial/lot number: (b)(6).Event date: (b)(6) 2023.How was issue noticed?: out of box failure.Procedure completed successfully?: no associated procedure.Patient involvement?: no - no impact.Medical intervention?: no associated procedure.Surgical delay?: no.Adverse consequences?: no.Adverse consequence details: na.Product available for return?: return.

Manufacturer Narrative

No patient harm reported.The device was returned for evaluation.The most possible root cause could not be determined at the moment and the investigation is still ongoing.The affected device was not used in an intraoperative procedure since damaging of the packaging was obvious.

Manufacturer Narrative

The end user returned the device for evaluation, and it was confirmed that the sterile barrier system has holes inside.The dhr of this product has been reviewed, there is no record of both defects.However, the reported case could happen due to the following causes: 1) hole on the unit packaging could be caused by an improper packing method which the unit pack need to befolded prior packing into carton.Based on the individual operator practice, the film of packaging could be damaged by the rigid component of product.2) unknown residual on the outside of packaging could be the residual of adhesive tape used for tapping the table at the packing operation.

• Brand Name: PNEUMOCLEAR HEATED HUMIDIFIED SMOKE EVACUATION TUBE SET
• Type of Device: CARBON DIOXIDE INSUFFLATOR FOR LAPAROSCOPY AND VESSEL HARVESTING
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; w.o.m. world of medicine gmbh; salzufer 8; berlin, berlin 10587 ; GM 10587
• Manufacturer (Section G): INFUS MEDICAL CO., LTD.; 55 moo 6, tambon banthum; amphoe muang, khon kaen province 40000 ; TH 40000
• Manufacturer Contact: sushira panchama ; w.o.m. world of medicine gmbh; salzufer 8; berlin, berlin 10587 ; GM 10587
• MDR Report Key: 17743734
• MDR Text Key: 323377066
• Report Number: 3002914049-2023-00011
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04056702001506
• UDI-Public: 04056702001506
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/14/2023

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 Model Number: ST298
• Device Catalogue Number: 0620050350
• Device Lot Number: K22M252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/18/2023
• Initial Date FDA Received: 09/14/2023
• Supplement Dates Manufacturer Received: 08/18/2023
• Supplement Dates FDA Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1