MAUDE Adverse Event Report: PROSURG PRO SURG CUTTING LOOP -27F; CUTTING LOOP - 27F

Model Number M0068802040

Device Problems Product Quality Problem (1506); Device Operates Differently Than Expected (2913); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2015

Event Type  malfunction  

Event Description

Prosurg cutting loop- 27f was placed in resectoscope.Loop fell apart - piece of loop became stuck in resectoscope and had to be sent out for repair.No harm to patient.Device is distributed by (b)(4).

• Brand Name: PRO SURG CUTTING LOOP -27F
• Type of Device: CUTTING LOOP - 27F
• Manufacturer (Section D): PROSURG; 2193 trade zone blvd; san jose CA 95131
• MDR Report Key: 5430852
• MDR Text Key: 38145213
• Report Number: 5430852
• Device Sequence Number: 1
• Product Code: FAS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: M0068802040
• Device Catalogue Number: 880-204
• Device Lot Number: 0215003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/29/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/09/2015
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR