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

Model Number 173016

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter: occurred during a laparoscopic hiatal hernia repair procedure.The suturing device was being used after the wrap of the stomach around the esophagus.The needle broke and fell into the cavity of the patient.It was not retrieved because of the part of the anatomy.There was no patient harm.

Manufacturer Narrative

Evaluation summary post market vigilance (pmv) led an evaluation of one device.Device had bent blades.Engineering found no evidence of malfunction of the device.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.However, the investigation detected a secondary condition of misuse that has no relationship to the reported incident.Replication of the bent blade indicates that the instrument may have been exposed to an external force which bent the exposed metal bars.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.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 Description

According to the reporter: occurred during a laparoscopic hiatal hernia repair procedure.The suturing device was being used after the wrap of the stomach around the esophagus.The needle broke and fell into the cavity of the patient.It was not retrieved because of the part of the anatomy.In order to resolve the issue and complete the case, the needle piece was left inside the patient and got a new suturing device.There was no additional patient harm.

• Brand Name: ENDO STITCH
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; noth haven, CT 06473 ; 2034925563
• MDR Report Key: 7318038
• MDR Text Key: 101650921
• Report Number: 9612501-2018-00381
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 20884521100005
• UDI-Public: 20884521100005
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 173016
• Device Catalogue Number: 173016
• Device Lot Number: J7H1201EX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other