MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY - AMERICA, INC. CLICKLINE FENESTRATED GRASP FORCEPS; FORCEPS, BIOPSY, NON-ELECTRIC

Catalog Number 33310ON

Device Problems Break (1069); Component Falling (1105)

Patient Problem No Code Available (3191)

Event Date 02/08/2018

Event Type  Injury  

Event Description

During a laparoscopic right inguinal hernia repair, the bowel grasper tip broke inside of the abdomen of the pt.The tip of the grasper was visualized by the surgeon and removed.There was no injury to the pt.

• Brand Name: CLICKLINE FENESTRATED GRASP FORCEPS
• Type of Device: FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section D): KARL STORZ ENDOSCOPY - AMERICA, INC. ; el segundo CA 90245
• MDR Report Key: 7464310
• MDR Text Key: 106721116
• Report Number: MW5076764
• Device Sequence Number: 1
• Product Code: NON
• Combination Product (y/n): N
• 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: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 33310ON
• 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: 69 YR
• Patient Weight: 67