MAUDE Adverse Event Report: COLOPLAST A/S DIGITEX SUTURE DELIVERY DEVICE; SUTURE DELIVERY SYSTEM

Model Number	5202502400
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
Event or Problem Description
According to the available information, digitex needle and cap were stuck together in the ss ligament after firing.Finally removed with a halstead by pulling down on the needle to pop and release.Needle/cap may have failed.Excess tissue captured between needle and cap may have been the cause.The procedure was delayed 60 minutes, no harm to patient.
Additional Manufacturer Narrative
One digitex device and one suture cartridge were received for evaluation.Examination and testing of the returned components by the head of quality, sr.Project manager and two post market surveillance specialists revealed the suture was still connected to the spool and the cap was still connected to the needle.The device fired normally and was not bound up.Tissue was noted in the head of the device.No abnormalities were noted with the digitex device or the suture.The information received indicated that the physician captured a large bite of the ligament tissue leading to the sds needle becoming stuck in the ss ligament and not capturing the suture cap.This complaint was forwarded to the contract manufacturer (cm) for review.The cm reviewed the manufacturing records for this device and confirmed that there were no discrepancies that would have contributed to this complaint and verified that the devices from this lot met all specifications prior to release.Management routinely reviews events such as this and monitors complaint levels.Additionally, events of this type are captured in the product risk documentation.Based on this information no further corrective action is required at this time.
Event or Problem Description
Additional information received from the physician indicated that when capturing the ligament, no excessive downward pressure was necessary, the usual amount of pressure was used.The physician stated he captured a large bite where the semicircle of the head was within the ligament and the bite was the entire diameter.Once the digitex was fired, the physician stated that it felt like the handle clicked and the handle would not release and spring back.In summary, the needle never captured the black cap of the suture and brought through the ligament.

• Brand Name: DIGITEX SUTURE DELIVERY DEVICE
• Common Device Name: SUTURE DELIVERY SYSTEM
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 7064983
• Report Number: 2125050-2017-00593
• Device Sequence Number: 19032504
• Product Code: GAW
• UDI-Device Identifier: 05708932440127
• UDI-Public: 05708932440127
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2018

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?: No
• Operator of Device: Physician
• Device Model Number: 5202502400
• Device Catalogue Number: 5202502400
• Device Lot Number: 5053933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/16/2017
• Supplement Date Received by Manufacturer: 11/16/2017
• Initial Report FDA Received Date: 11/28/2017
• Supplement Report FDA Received Date: 01/09/2018
• 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: Other