MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC. DOUBLE ACTION JAW; BIOPSY FORCEP RIGID, NON-ELECTRIC

Model Number 27071ZJ

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 10/24/2019

Event Type  Injury  

Event Description

Urological biopsy forceps malfunction while in use.No piece of the biopsy forceps remained in the bladder.

• Brand Name: DOUBLE ACTION JAW
• Type of Device: BIOPSY FORCEP RIGID, NON-ELECTRIC
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA, INC.; 2151 e. grand avenue; el segundo CA 90245
• MDR Report Key: 9310560
• MDR Text Key: 166153569
• Report Number: MW5090992
• Device Sequence Number: 1
• Product Code: OCZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27071ZJ
• Device Lot Number: RR01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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 Outcome(s): Required Intervention
• Patient Age: 17 YR
• Patient Weight: 42