MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON MAX GR 1X27 T16 4/0; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	8886621731
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	02/03/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
According to the reporter: during the extraction of the thread, the needle detached in the trocar and was not found.A intraoperative radioscopy was needed.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
According to the reporter: due to the device issue the operation time had to extended (duration not provided), and it was also necessary to scope the patient to try and find the needle which was never found in the patient.It was also provided that there was no tissue damage, no additional blood loss, no extension of an incision and no injury or consequence to the patient.The current patient status is good.No additional patient details could be provided.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of six sealed devices.This evaluation was based on a technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends, and an evaluation of the returned product.The visual inspection and functional evaluation of the products had acceptable results.The returned products were found to meet quality release specifications after application in the clinical setting and the reported conditions were not confirmed.A review of the device history record indicates this device lot number was released meeting all quality release specifications at the time of manufacture.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate (b)(4).

• Brand Name: MAX GR 1X27 T16 4/0
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• MDR Report Key: 5466261
• Report Number: 1219930-2016-00171
• Device Sequence Number: 281813
• Product Code: GAM
• UDI-Device Identifier: 10884523002331
• UDI-Public: 10884523002331
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K990951
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/06/2016

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: 8886621731
• Device Catalogue Number: 8886621731
• Device Lot Number: B5G1270WX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/08/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/29/2016
• Supplement Report FDA Received Date: 04/06/2016; 05/25/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR