MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SURGIDAC; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number	173023
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Entrapment of Device (1212); Human-Device Interface Problem (2949)
Health Effect - Clinical Codes	Tissue Damage (2104); No Code Available (3191)
Date of Event	06/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, while attempting to over sew the anastomosis on a laparoscopic roux en y gastric bypass, the surgeon was unable to toggle the needle to the other jaw.The tissue was tenting around the needle, however the needle would not pierce completely through.This resulted in tissue being jammed into the other jaw with the needle.The surgeon tried a number of times to toggle back and forth through the tissue but unable to complete the transition of the needle from the jaw to the other.The surgeon struggled to removed the needle from the tissue and experienced some serosal tearing while using grasper to remove tissue from the needle.This resulted to extended time of more than 30 minutes due to the surgeon used standard laparoscopic suture and needle drivers in place of the device to complete the case.

• Brand Name: SURGIDAC
• Common Device Name: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 7642930
• Report Number: 9612501-2018-01210
• Device Sequence Number: 2435171
• Product Code: OCW
• UDI-Device Identifier: 10884521129443
• UDI-Public: 10884521129443
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K934738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/27/2018

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 Model Number: 173023
• Device Catalogue Number: 173023
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 06/27/2018
• 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: Required Intervention
• Patient Age: 25 YR
• Patient Weight: 126