MAUDE Adverse Event Report: STORZ GERMANY FORCEPS

Model Number 270712

Device Problem Break (1069)

Patient Problem Laceration(s) (1946)

Event Date 10/23/2014

Event Type  Injury  

Event Description

(b)(6) male sustained linear scratch on urethra when biopsy forceps broke inside bladder during cystoscopy.Forceps piece retrieved with no harm to pt.

• Brand Name: FORCEPS
• Type of Device: FORCEPS
• Manufacturer (Section D): STORZ GERMANY
• MDR Report Key: 4379946
• MDR Text Key: 5289300
• Report Number: MW5039895
• Device Sequence Number: 1
• Product Code: FAJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/02/2014

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: 270712
• Device Lot Number: NONE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 7 YR
• Patient Weight: 29