MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD POLYSORB; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	XX-5202J
Medical Device Problem Codes	Detachment Of Device Component (1104); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2018
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 total laparoscopic hysterectomy procedure, the needle had detached from the suture.The part fell into the patient's cavity and was retrieved.The needle was found inside the trocar.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) received twenty sealed devices with the appropriate packaging in an undamaged condition and one device opened by the account with the appropriate packaging in an undamaged condition.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.However, an assembly error was identified during product analysis.The root cause of the reported condition was an improper execution of in-process controls for material assignment.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a total laparoscopic hysterectomy procedure, the needle had detached from the suture and was missing.The part fell into the patient's cavity and was retrieved.The needle was found inside the trocar.The surgeon used a different device to complete the case.The surgical time was extended by less than 30 min.There was no patient injury.

• Brand Name: POLYSORB
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 7228890
• Report Number: 9612501-2018-00129
• Device Sequence Number: 1223182
• Product Code: GAM
• UDI-Device Identifier: 20884521154664
• UDI-Public: 20884521154664
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K963253
• 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
• Report Date (Section B): 05/18/2018

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: 10/31/2022
• Device Model Number: XX-5202J
• Device Catalogue Number: XX-5202J
• Device Lot Number: D7K1938X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Initial Date Received by Manufacturer: 01/15/2018
• Supplement Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 01/30/2018
• Supplement Report FDA Received Date: 05/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1