MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SURGIDAC; ENDOSCOPE AND/OR ACCESSORIES

Model Number	173021
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	05/31/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter: occurred during a laparoscopic roux-en-y gastric bypass.While suturing the anastomosis, the needle disengaged.It did not disengage into the patient cavity.To complete the procedure, another loading unit was used.No patient injury or extension in surgical time.Patient status is alive, no injury.
Additional Manufacturer Narrative
Device evaluation: post market vigilance (pmv) led an evaluation of one suturing device.The instrument was severely bent where the shaft joins the housing.The plastic housing was broken and a needle was jammed in the jaws.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the observed condition may occur if excess force is used when the collar is pushed forward to cover the l-hook.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: occurred during a laparoscopic roux-en-y gastric bypass.While suturing the anastomosis, the suture came out of the swedge of the needle.The needle did not disengage from the handle.It did not disengage into the patient cavity.To complete the procedure, another loading unit was used.No patient injury or extension in surgical time.Patient status is alive, no 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: occurred during a laparoscopic roux-en-y gastric bypass.While suturing the anastomosis, the suture came out of the swedge of the needle.The needle did not disengage from the handle.It did not disengage into the patient cavity.To complete the procedure, another loading unit was used.No patient injury or extension in surgical time.Patient status is alive, no injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURGIDAC
• Common Device Name: ENDOSCOPE AND/OR ACCESSORIES
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 6669304
• Report Number: 9612501-2017-05682
• Device Sequence Number: 13508167
• Product Code: KOG
• UDI-Device Identifier: 20884521129433
• UDI-Public: 20884521129433
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K934738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/11/2017

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: 01/31/2022
• Device Model Number: 173021
• Device Catalogue Number: 173021
• Device Lot Number: J7A1464X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2017
• Initial Date Received by Manufacturer: 06/01/2017
• Supplement Date Received by Manufacturer: 06/28/2017; 06/28/2017; 08/11/2017
• Initial Report FDA Received Date: 06/27/2017
• Supplement Report FDA Received Date: 07/27/2017; 09/07/2017; 09/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 109