MAUDE Adverse Event Report: COVIDIEN NORTH HAVEN - MFG POLYSORB; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	GL-125
Medical Device Problem Codes	Break (1069); Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/01/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter: during open hysterectomy procedure the part of the needle broke off while suturing pelvic tissue.X-ray was used to try to locate the broken piece, suspected identification on (b)(6) 2017 but could not be retrieved / found, the surgical time extended due to the product problem.The device had been opened or removed from the packaging prior to use for 5 minutes.An additional new suture was used without issue.Patient status : alive- no injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: POLYSORB
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN NORTH HAVEN - MFG; 195 mcdermott road; north haven CT 06473
• MDR Report Key: 6499629
• Report Number: 1219930-2017-05313
• Device Sequence Number: 1458108
• Product Code: GAM
• UDI-Device Identifier: 20884521044996
• UDI-Public: 20884521044996
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2017

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: 04/30/2021
• Device Model Number: GL-125
• Device Catalogue Number: GL-125
• Device Lot Number: A6D0062X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/05/2017
• Supplement Date Received by Manufacturer: 04/05/2017
• Initial Report FDA Received Date: 04/18/2017
• Supplement Report FDA Received Date: 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other