MAUDE Adverse Event Report: COVIDIEN CHROMIC GUT 3/0 30 V-20 102Q; CHROMIC GUT ABSORBABLE SUTURE

Model Number GG122

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

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

Event Date 01/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device has not been received.A supplemental report will be sent if device is received.

Event Description

According to the reporter, the tip of the needle broke off while sewing rectal tissue.They were able to retrieve the tips that broke off.The condition of the patient is unknown.There was no re-operation, etc.There was no unanticipated tissue loss.The incision was not extended by more than one inch.There was no unanticipated blood loss of 500 cc or more.Surgery time was not delayed by more than 30 minutes.The device fragment fell into the patient but was retrieved from the cavity.No reinforcement material was used.Additional information has been requested but not yet received.A supplemental report will be submitted upon receipt of new information.

• Brand Name: CHROMIC GUT 3/0 30 V-20 102Q
• Type of Device: CHROMIC GUT ABSORBABLE SUTURE
• Manufacturer (Section D): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer (Section G): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6296982
• MDR Text Key: 66446545
• Report Number: 9612501-2017-00200
• Device Sequence Number: 1
• Product Code: GAL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K885018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/06/2017

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 Expiration Date: 04/30/2019
• Device Model Number: GG122
• Device Catalogue Number: GG122
• Device Lot Number: D4D1482GX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/06/2017
• Initial Date FDA Received: 02/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• 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