MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE PROCEDURE SET; STAPLE, IMPLANTABLE

Catalog Number PPH03

Device Problems Component Falling (1105); Crack (1135)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/29/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4) date sent: 8/18/2015 at the time of this submission, the device has not been returned for analysis.If the device is received at a later date a supplemental medwatch will be sent.Comments: the event description can be confirmed.The washer is uncut indicating that the firing stroke was not completed.Potential causes of not completing the firing stroke are; the tissue unevenly loaded in the device causing the anvil to become off center with the knife (this allows the knife to make contact with the anvil and interferes with the firing stroke), uneven loading of the tissue that causing the force to fire to increase making the user believe the firing stroke is completed, and the user not delivering enough force to the handle to cut the washer.Based on the photo evidence and the information in the event description, the device firing stroke was interrupted and it was not subjected to a complete firing (plastic to plastic).Conclusion: based on the photos provided, the event description can be confirmed.The device was not subjected to a full firing stroke.Hands on device analysis should be able to generate the evidence necessary to confirm the root cause of the reported event.

Event Description

It was reported that during a stapler rectopexy procedure, "after taking purse string suture and fixed the anvil and after closing the stapler i fired it.The prolene suture fell down cut.I did not hear any plastic ring cracking noise of stapler when fired.Waited for 2 min and removed the gun.Torrential bleed happened and examination showed cut mucosa was hanging like two ears on both sides and rectal mucosa splayed up.Examination of stapler showed no donut in the housing and the plastic ring was found not broken and there was no stapler pins in the plastic ring or in the plastic in housing.Examination inside anus also revealed no stapler in the mucosa.With lot of care, the cut ends of rectum and anus were approximated using 3-0 vicryl after trimming the resected mucosa.".

Manufacturer Narrative

(b)(4).Additional information: batch # l54a1n.Additional information received: what is the current status of the patient? as on now doing well.What was the hemorrhoid grade? it was prolapsed piles grade - iv.What was the quality of the tissue? good.There was no donut in the housing.The resected rectal mucosa was hanging like two halves inside the lumen and it was bleeding profuse.In order to approximate the mucosal divided end the resected mucosa was trimmed and sent for hpe.Enclosed the report.Biopsy consistent with hemorrhoids.Were any of the forces higher or lower than expected (closing, firing, or opening)? no when the device was fired, what was the location of the indicator within the gap setting scale (top/thin, middle/medium, bottom/thick)? the green line was in the end.Were there any issues encountered with uneven tissue loading? it was perfect purse string.But the prolene suture was cut by stapler without any stapler pins inside rectum or there was no stapler pins in the device.

Manufacturer Narrative

(b)(4).Batch # l54a1n.Additional information received: comments: the event description can be confirmed.The washer is uncut indicating that the firing stroke was not completed.Potential causes of not completing the firing stroke are; the tissue unevenly loaded in the device causing the anvil to become off center with the knife (this allows the knife to make contact with the anvil and interferes with the firing stroke), uneven loading of the tissue that causing the force to fire to increase making the user believe the firing stroke is completed, and the user not delivering enough force to the handle to cut the washer.Based on the photo evidence and the information in the event description, the device firing stroke was interrupted and it was not subjected to a complete firing (plastic to plastic).Conclusion: based on the photos provided, the event description can be confirmed.The device was not subjected to a full firing stroke.Hands on device analysis should be able to generate the evidence necessary to confirm the root cause of the reported event.

• Brand Name: PROXIMATE PROCEDURE SET
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 5013630
• MDR Text Key: 23419648
• Report Number: 3005075853-2015-05157
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K051301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 07/30/2015

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
• Device Operator: Health Professional
• Device Catalogue Number: PPH03
• Device Lot Number: L54A1N
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/08/2014
• 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