MAUDE Adverse Event Report: ESI Weco Manufacturing Group / Weco Manufacturing Group-Henrietta Salvati Operating Proctoscope

Model Number	15-4010
Medical Device Problem Codes	Device Reprocessing Problem (1091); Use of Device Problem (1670); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Esi-electrosurgical instrumest salvati proctoscope 15-4010: multiple product (2) arrived new, was reprocessed once each using manual cleaning with fda registered cleaning agent prepared per ifu and aami water standards; sent through fda registered washer/disinfector using a fda registered cleaning agent prepared per ifu.All device reprocessing instructions followed as required per the manufacturer ifu.Product was then packaged and sterilized with a steris fda registered autoclave at the pre-vacuum steam sterilization parameters per the device ifu at 270*f, 4-minute exposure.Once completed product was opened to be used for a patient procedure and was found to be defective.The salvati proctoscope consists of 2 pieces, an inner plastic piece and an outer metal piece.After reprocessing 1-time, the inner plastic piece could not be assembled into the outer metal piece and unable to be used.The surgeon had to used rectal retractor's instead creating a less than ideal surgical situation.No harm was done and procedure was completed.A second salvati was purchased new and the exact same issue occurred.Both salvati proctoscopes could not be used due to the inner plastic piece not fitting into the outer metal sleeve.Devices unable to be used.Inner plastic piece fit into the outer metal piece prior to reprocessing, all device reprocessing steps followed per ifu, prolystica ph neutral enzymatic detergent, the getinge washer/disinfector, and the steris amsco steam sterilizer were used per each devices ifu.Issue was reported to device manufacturer.Reference report mw6001216.Annex a: 2588, 1670, 1091.Annex e: 4582.Annex f: 4642.Annex g: 4723.This report captures salvati operating proctoscope stainless #1.

• Brand Name: Salvati Operating Proctoscope
• Common Device Name: Proctoscope
• Manufacturer (Section D): ESI Weco Manufacturing Group / Weco Manufacturing Group-Henrietta
• MDR Report Key: 50302190
• Report Number: MW6001215
• Device Sequence Number: 18654134
• Product Code: GCF
• UDI-Device Identifier: B3961540100
• UDI-Public: +B3961540100/$$752873/16D20260722B
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/12/2026

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 Model Number: 15-4010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/18/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown