MAUDE Adverse Event Report: SYNERGY HEALTH SOVEREIGN ATRAUMATIC GRASPER, SINGLE ACTION, 5MM, 42CM; LAPAROSCOPY KIT

Model Number PL049R

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/02/2016

Event Type  malfunction  

Manufacturer Narrative

Device has not been returned to synergy health for evaluation.Complaint originator (orange coast medical) is holding device until their investigation is complete.Once returned, device will be sent to aesculap for evaluation.Risk manager ((b)(4)) for orange coast medical was contacted on (b)(4) 2016 to follow up in regards to the initial data received.He verbally confirmed all pieces were retrieved and no adverse event occurred and no patient injury involved.

Event Description

Tip of the grasper broke off inside a patient.All pieces retrieved and accounted for.Event did not cause harm.Equipment failure without injury.

• Brand Name: SOVEREIGN ATRAUMATIC GRASPER, SINGLE ACTION, 5MM, 42CM
• Type of Device: LAPAROSCOPY KIT
• Manufacturer (Section D): SYNERGY HEALTH; 2240 e artesia blvd; long beach CA 90805
• Manufacturer (Section G): SYNERGY HEALTH; 2240 e artesia blvd; long beach CA 90805
• Manufacturer Contact: justin matchett ; 401 e jackson street; suite 3100; tampa, FL 33602 ; 562-428-58
• MDR Report Key: 5880445
• MDR Text Key: 53447615
• Report Number: 0002028626-2016-00001
• Device Sequence Number: 1
• Product Code: FDE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 08/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PL049R
• Device Lot Number: 427202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention