MAUDE Adverse Event Report: W.O.M. WORLD OF MEDICINE GMBH HYSTEROLUX HYSTEROSCOPIC INFLOW TUBE SET; LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Model Number	ST261
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
We have been informed of the following event: mfr report # mw5112799: covidien hysterolux hysteroscopic inflow tube set- packaging arrived with no lot#, no expiration date and no manufacture date listed.Product not used and returned to manufacturer.Additional information provided by the distributor: "08.11.2022 hs: for this one since we have such limited information, including no contact information, we cannot send a request to anyone asking for the product to be returned.We have filed it under (b)(4), product:72205028, item:10, lot no:unknown.For now, after talking to our people, we can close it as a no sample as we are not expecting to get the product back at this time.In the off chance that we do get product returned that is somehow tied to the medwatch or the pe we can reopen the complaint and amend the file at that time.I have closed it as a no sample today.".

• Brand Name: HYSTEROLUX HYSTEROSCOPIC INFLOW TUBE SET
• Common Device Name: LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8; berlin, 10587 ; GM 10587
• Manufacturer (Section G): W.O.M. WORLD OF MEDICINE GMBH; alte poststrasse 11; ludwigsstadt, 96337 ; GM 96337
• Manufacturer Contact: giese ; salzufer 8; berlin, 10587 ; GM 10587
• MDR Report Key: 15864221
• Report Number: 3002914049-2022-00011
• Device Sequence Number: 12488060
• Product Code: HET
• UDI-Device Identifier: 04056702005795
• UDI-Public: 04056702005795
• Combination Product (Y/N): Y
• PMA/510(K) Number: K173489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial

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 Model Number: ST261
• Device Catalogue Number: 72205028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2022
• Initial Report FDA Received Date: 11/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Patient Sequence Number: 1
• Patient Sex: Unknown