MAUDE Adverse Event Report: G. HIPP AND SOHN SURE GRIP TISSUE GRASPER; RONGUER/GRASPER

Model Number 3645-02

Device Problem Material Fragmentation (1261)

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

Event Date 06/10/2014

Event Type  malfunction  

Event Description

Spike of sure grip soft tissue grasper fell off during the second use.The spike was sequestered.No injuries were sustained by the patient.

• Brand Name: SURE GRIP TISSUE GRASPER
• Type of Device: RONGUER/GRASPER
• Manufacturer (Section D): G. HIPP AND SOHN; neuhausen ob eck ; GM
• Manufacturer (Section G): INNOMED CORP.; 103 estus dr.; savannah GA 31404
• Manufacturer Contact: 103 estus dr.; savannah, GA 31404
• MDR Report Key: 3919014
• MDR Text Key: 4517723
• Report Number: 1833053-2014-00002
• Device Sequence Number: 1
• Product Code: HXT
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3645-02
• Device Catalogue Number: 3645-02
• Device Lot Number: 0512GH
• Other Device ID Number: 00840277105943
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/23/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/26/2014
• Device Age: 29 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/26/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1