MAUDE Adverse Event Report: ZIPLINE MEDICAL ZIP SURGICAL SKIN CLOSURE DEVICE; TAPE BASED WOUND CLOSURE

Model Number PS2080

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Wound Dehiscence (1154)

Event Date 07/25/2018

Event Type  Injury  

Manufacturer Narrative

The zip surgical skin closure device was placed on the patient's knee while the knee was in the fully extended position (0 degrees flexion), which is contrary to the information provided in the product instructions for use.When the patient flexed the knee post-operatively, the device immediately lost adhesion.Loss of device adhesion as a result of failure to flex the knee prior to device application is a known risk that is documented in the product risk documentation, as well as in the precautions section of the instructions for use.

Event Description

Zip surgical skin closure device lost adhesion when patient flexed their knee post-operatively.Physician intervened by removing the device and closing the incision with sutures.No other complications were reported.

• Brand Name: ZIP SURGICAL SKIN CLOSURE DEVICE
• Type of Device: TAPE BASED WOUND CLOSURE
• Manufacturer (Section D): ZIPLINE MEDICAL; 747 camden ave.; suite a; campbell CA 95008
• Manufacturer (Section G): ZIPLINE MEDICAL; 747 camden ave.; suite a; campbell CA 95008
• Manufacturer Contact: arleen felt ; 747 camden ave.; suite a; campbell, CA 95008 ; 4086840748
• MDR Report Key: 8053607
• MDR Text Key: 126632971
• Report Number: 3009673389-2018-00003
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: 510K EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: PS2080
• Device Catalogue Number: PS2080
• Device Lot Number: 0000083251
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2018
• Initial Date FDA Received: 11/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention