MAUDE Adverse Event Report: HERMANN MEDIZINTECHNIK GMBH CLIP APPLICATOR, 10 X 330 MM, FOR CLIPS

Model Number H30-135-883E

Device Problem Device Handling Problem (3265)

Patient Problem Perforation of Vessels (2135)

Event Date 12/10/2018

Event Type  malfunction  

Event Description

The user reported that while using clip applicator, there was an incident of a blood vessel being cut while trying to apply a clip.Another incident happened when cystic duct was cut.

• Brand Name: CLIP APPLICATOR, 10 X 330 MM, FOR CLIPS
• Type of Device: CLIP APPLICATOR
• Manufacturer (Section D): HERMANN MEDIZINTECHNIK GMBH; wuerttembergstr. 26; fridingen, baden-wuerttemberg 78567 ; GM 78567
• Manufacturer (Section G): HERMANN MEDIZINTECHNIK GMBH; wuerttemberg str. 26; fridingen, baden-wuerttemberg 78567 ; GM 78567
• Manufacturer Contact: daniela hermann ; wuerttemberger str. 26; fridingen, baden-wuerttemberg 78567 ; GM 78567
• MDR Report Key: 8288103
• MDR Text Key: 136988276
• Report Number: 8010257-2019-00001
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: LH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/10/2019

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: H30-135-883E
• Device Lot Number: 60234
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2018
• Initial Date FDA Received: 01/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention