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

Model Number	CL-779
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	01/12/2018
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during the removal of uterus cyst, while the doctor was passing the needle from the uterus, employing a continued technique, the needle suddenly broke.Surgery extended for more than an hour, because it was difficult for the doctor to find the broken needle.Patient was not injured or jeopardized.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned samples noted one partial suture and one needle.The needle was broken at the swaged end.The broken swaged end of the needle was attached to the partial suture.As no sealed products were returned, functional testing was precluded.A review of the device history record indicates the product 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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during the removal of uterus cyst, while the doctor was passing the needle from the uterus, employing a continued technique, the needle suddenly broke.Surgery extended for more than an hour, because it was difficult for the doctor to find the broken needle.A new suture was used in order to complete the case.Patient was not injured or jeopardized.

• 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: 7228856
• Report Number: 9612501-2018-00127
• Device Sequence Number: 986925
• Product Code: GAM
• UDI-Device Identifier: 20884521041797
• UDI-Public: 20884521041797
• 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,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2018

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: 02/28/2022
• Device Model Number: CL-779
• Device Catalogue Number: CL-779
• Device Lot Number: D7B1382X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Initial Date Received by Manufacturer: 01/12/2018
• Supplement Date Received by Manufacturer: 03/01/2018
• Initial Report FDA Received Date: 01/30/2018
• Supplement Report FDA Received Date: 03/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 63