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

Model Number	GL-224
Medical Device Problem Codes	Bent (1059); Break (1069); Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a laparoscopic cholecystectomy, the suture needle bends easily and it broke.A portion of the suture needle fell into the patient cavity and they were able to completely retrieve the broken piece from the patient¿s cavity.They noted that this event resulted in significant time loss and it made it harder to complete the suturing.There was no patient injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a laparoscopic cholecystectomy, the suture needle bends easily and it broke.A portion of the suture needle fell into the patient cavity and they were able to completely retrieve the broken piece from the patient¿s cavity via surgical forceps.They noted that this event resulted in significant time loss and it made it harder to complete the suturing.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.A tactile and microscopic inspection of the sutures was performed with no abnormalities.The foil was inspected with light assisted microscopy with no abnormalities.The sealed sample was sent for bend moment testing and the results exceeded the specifications for this product.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a laparoscopic cholecystectomy, the suture needle bends easily and it broke.A portion of the suture needle fell into the patient cavity and they were able to completely retrieve the broken piece from the patient¿s cavity via surgical forceps.They noted that this event resulted in significant time loss and it made it harder to complete the suturing.There was no patient injury.

• Brand Name: POLYSORB
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7533093
• Report Number: 1219930-2018-02801
• Device Sequence Number: 156892
• Product Code: GAM
• UDI-Device Identifier: 10884521045163
• UDI-Public: 10884521045163
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K963253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/05/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: GL-224
• Device Catalogue Number: GL-224
• Device Lot Number: A7J0571X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 05/29/2018; 08/17/2018
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 06/14/2018; 09/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR