MAUDE Adverse Event Report: GYRUS MEDICAL LTD. / OLYMPUS WINTER & IBE GMBH RESECTOSCOPE ; COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/06/2020

Event Type  No Answer Provided  

Event Description

During the transurethral resection of bladder tumor, the ceramic tip of the resectoscope was broken.The broken pieces were retrieved and thrown away prior to reporting the incident.The instrument was replaced in the tray by sps.Discussed the case with operating room mgr, surgeon and contacted the company rep.Surgeon mentioned that he is unfamiliar with a particular aspect of this resectoscope.We contacted the company to educate the surgeon and be there for next couple of cases until the surgeon familiarizes himself.

• Brand Name: RESECTOSCOPE
• Type of Device: COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)
• Manufacturer (Section D): GYRUS MEDICAL LTD. / OLYMPUS WINTER & IBE GMBH
• MDR Report Key: 9753187
• MDR Text Key: 181157964
• Report Number: MW5093261
• Device Sequence Number: 1
• Product Code: HFG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/25/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 114