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

Model Number UNKNOWN ENDO STITCH SULU

Device Problems Component or Accessory Incompatibility (2897); Difficult to Open or Close (2921); Human-Device Interface Problem (2949)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, during a laparoscopic procedure, the scrub tech was struggling with both the loading and unloading of the instrument in use.The doctor was also having difficulty using it and demonstrated how the instrument would not open fully within the patient after passing the needle, how the needle would stick within the tissue (jaws closed) as he was passing the needle.The doctor indicated that the experience with the instrument was similar to what had occurred with the previous 3 procedures.Opened another instrument to complete the procedure.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection and functional testing confirmed there were no abnormalities that would have caused or contributed to the reported condition.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a laparoscopic procedure, the scrub tech was struggling with both the loading and unloading of the instrument in use.The doctor was also having difficulty using it and demonstrated how the instrument would not open fully within the patient after passing the needle, how the needle would stick within the tissue (jaws closed) as he was passing the needle.Opened another instrument to complete the procedure.There was no patient injury.

• Brand Name: UNKNOWN ENDO STITCH SULU
• 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.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 8276617
• MDR Text Key: 134061917
• Report Number: 9612501-2019-00151
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN ENDO STITCH SULU
• Device Catalogue Number: UNKNOWN ENDO STITCH SULU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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