MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COUPLER HD 17.2MM AUTOCLAVABLE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	72204725
Medical Device Problem Code	Optical Discoloration (2999)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that during set up of the equipment, the camera coupler was connected and showed a green view.They tried to connect and test it once more, obtaining the same result.The procedure was canceled as there was no backup device.The patient is stable as the procedure was rescheduled.
Additional Manufacturer Narrative
H11: h2: upon re-evaluation of the information received, it has been determined that this event does not meet the criteria for medical device reporting (mdr) to the fda and is considered non-reportable.Although the surgical procedure was ultimately canceled, the cancellation occurred prior to the induction of anesthesia, and the patient had not yet been exposed to the surgical intervention.Therefore, based on the available information and in accordance with applicable mdr regulations, this event does not constitute a reportable incident.Should additional details become available that indicate the occurrence of a reportable event, the case will be reassessed, documentation will be updated, and a follow-up report will be submitted as required.

• Brand Name: COUPLER HD 17.2MM AUTOCLAVABLE
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: holly topping ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 22181696
• Report Number: 3003604053-2025-00022
• Device Sequence Number: 21005239
• Product Code: GCJ
• UDI-Device Identifier: 00885556616727
• UDI-Public: 885556616727
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K153606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 72204725
• 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: 05/19/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown