MAUDE Adverse Event Report: RICHARD WOLF GMBH E-LINE; RESECTOSCOPE, WORKING ELEMENT

Model Number 86543742

Device Problem Break (1069)

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

Event Date 03/17/2021

Event Type  malfunction  

Event Description

Narrative from staff: during the procedure, the end of the scope broke off and was discovered in the bladder at the end while morcellating the prostate chips.Narrative from operative report: beak of scope broke during the case and was in the bladder, this was removed with the morcellator-scope and a flexible scope.A 22fr 3-way catheter was placed with 20 cc in balloon, continuous irrigation and patient returned to recovery with clear urine.

• Brand Name: E-LINE
• Type of Device: RESECTOSCOPE, WORKING ELEMENT
• Manufacturer (Section D): RICHARD WOLF GMBH; 353 corporate woods pkwy.; vernon hills IL 60061
• MDR Report Key: 11559635
• MDR Text Key: 241950786
• Report Number: 11559635
• Device Sequence Number: 1
• Product Code: FDC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/19/2021

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: 86543742
• Device Catalogue Number: 8654.3742
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/19/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/24/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22995 DA
• Patient Weight: 87