MAUDE Adverse Event Report: RICHARD WOLF GMBH SHARK/S-LINE; CUTTING ELECTRODE BIPO STERILE, FOR SINGLE USE

Model Number	4624.1313
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Rwmic has requested additional and missing information from user facility and manufacturer.Rwmic will submit a follow up report upon receipt of additional information as appropriate.Rwmic consider this case open.
Event or Problem Description
On june 10th, 2019, rwmic was notified that report mw5087014 was submitted to fda from the user facility.User facility reported the following: during cystoscopy, transurethral resection of prostate with bipolar loop, the loop (tip) of the 26fr bipolar electrode broke off inside the patient.Surgeon unable to visualize the broken piece inside the patient using the cystoscope.Removed remainder of electrode from sterile field, placed in biohazard bag with package.X-ray taken negative for foreign body.

• Brand Name: SHARK/S-LINE
• Common Device Name: CUTTING ELECTRODE BIPO STERILE, FOR SINGLE USE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 8759049
• Report Number: 1418479-2019-00030
• Device Sequence Number: 2296850
• Product Code: JOS
• UDI-Device Identifier: 04055207048924
• UDI-Public: 04055207048924
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K062720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/10/2019
• Report Date (Section F): 07/03/2019

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 Expiration Date: 02/28/2023
• Device Model Number: 4624.1313
• Device Catalogue Number: 4624.1313
• Device Lot Number: 4500242351
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/10/2019
• Event Location: Hospital
• Date Report to Manufacturer: 07/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 07/03/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 07/03/2019