MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION JARIT RETRACTOR, SELF-RETAINING

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

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

Event Date 03/30/2016

Event Type  malfunction  

Event Description

Surgeon placed grasper in through trocar to use on a laparoscopic cholecystectomy. When surgeon opened grasper to use the working side broke off and fell into abdomen. Piece retrieved, no injury to patient.

• Brand Name: JARIT
• Type of Device: RETRACTOR, SELF-RETAINING
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 4900 charlemar drive; bldg a,; cincinnati, OH 45227
• MDR Report Key: 5614283
• MDR Text Key: 43880722
• Report Number: 5614283
• Device Sequence Number: 1
• Product Code: PKE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/21/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: Yes

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/21/2016
• Event Location: Hospital
• Date Report to Manufacturer: 04/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage